Invitae and ArcherDX to create a global leader in comprehensive cancer genetics and precision oncology

— Combination to bring germline and somatic testing, liquid biopsy and tissue genomic profiling onto a single platform to offer patients a full suite of cancer testing for risk, therapy optimization and personalized cancer monitoring —
— Provides unrivaled breadth and flexibility for clinicians, democratizing the use of genetics in routine care worldwide —
— Hosting webcast for investors today at 5:00 a.m. PT / 6:00 a.m. MT / 8:00 a.m. ET —

SAN FRANCISCO and BOULDER, COLO., June 22, 2020 — Invitae (NYSE: NVTA), a leading genetics company, and ArcherDX, a leading genomics analysis company democratizing precision oncology, today announced the companies have entered into a definitive agreement under which Invitae will combine with ArcherDX to create a genetics leader with unrivaled breadth and scale in cancer genetics and precision oncology.

The combined company will be poised to transform care for cancer patients, accelerating adoption of genetics through the most comprehensive suite of products and services available. Integrating germline testing, tumor profiling and liquid biopsy technologies and services in a single platform will enable precision approaches from diagnostic testing to therapy optimization and monitoring, expanding access to best-in-class personalized oncology.

“From the beginning, Invitae’s goal has been to aggregate the world’s genetic tests into a single platform in service of our mission to bring comprehensive genetic information into mainstream medicine. Today, we take another major step forward in that effort,” said Sean George, Ph.D., co-founder and chief executive officer of Invitae.

“ArcherDX and Invitae share a foundational belief in the power of genomic information to impact care. We are thrilled to unite with Invitae to form the leading hub for precision oncology, diagnostics, therapy optimization and monitoring, with an opportunity to accelerate both patient care and shareholder value,” said Jason Myers, Ph.D., chief executive officer and co-founder of ArcherDX. “ArcherDX was founded to democratize precision oncology with best-in-class products that are personal, actionable and available in local care settings. We see STRATAFIDEDX™ as a significant near-term value driver, currently under development for cancer therapy optimization, while PCM™ provides an exciting opportunity to transform cancer care through multiple monitoring applications. ArcherDX products, workflow and powerful bioinformatics solutions provide an opportunity to advance precision oncology into regional and community settings and address an estimated $45 billion market opportunity. Together with Invitae, we look forward to expanding our impact beyond oncology, driving significant value through shared expertise to inform healthcare throughout life, globally.”

“Integrating all aspects of cancer genetics can transform care for patients and the flexibility that comes from both centralized and decentralized capabilities will uniquely position Invitae to meet the needs of customers worldwide,” continued Dr. George. “By joining together, we will unite world-class capabilities in the hands of a talented team with complementary expertise and strong brands in service of a shared goal to improve healthcare for patients.”

Accelerating access and adoption of genetics to improve cancer care

Broad adoption of precision oncology has been limited, particularly in regional and community settings where approximately 85 percent of patients receive care. Without precision oncology, late-stage cancer patients can suffer from poor prognosis and outcomes, while early-stage patients may receive an inaccurate prognosis that results in unnecessary treatment and delayed detection of recurrence. ,

Uniting Invitae and ArcherDX will offer comprehensive support for precision oncology.

  •  Invitae has quickly become a leader in diagnostic and hereditary risk testing and has strong relationships with clinicians caring for cancer patients, including cancer genetic counselors, oncologists and imaging centers.
  • ArcherDX’s platform, with its proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled it to develop industry-leading products and services under investigation to optimize therapy and enable cancer monitoring across liquid and tissue samples.
  •  ArcherDX has developed and commercialized over 325 unique products, including research products and services in use by more than 300 laboratories worldwide and has collaborated with more than 50 biopharmaceutical companies and contract research organizations (CROs), providing services that enable biopharmaceutical companies, including partners such as AstraZeneca, BMS and Bayer, to cost-effectively accelerate drug development.
  • ArcherDX is also currently developing in-vitro diagnostic (IVD) products, including STRATAFIDEDX™, for therapy optimization, an estimated $5 billion market opportunity with U.S. Food and Drug Administration (FDA) submissions planned this year, and the broadly applicable Personalized Cancer Monitoring (PCM) in development for disease recurrence monitoring, therapy optimization including selection, response and modulation. Both STRATAFIDEDX™ and PCM have received Breakthrough Device designation from the FDA.
  • Together, the company will be ideally positioned to serve customers across the continuum, from individuals and community clinicians to biopharmaceutical partners, distribution partners, reference laboratories and academic centers. Invitae’s central laboratory provides support for customers who prefer to send out and can benefit from a full suite of services including reporting, clinician consultation and genetic counseling for patients, while ArcherDX’s decentralized model supports geographies and customers where local control of patient reporting is either desired or required.

With both centralized and local testing capabilities, the combined organization will offer breadth and flexibility in serving customers in more than 95 markets. Together, Invitae and ArcherDX will offer robust support for biopharmaceutical companies, from patient identification and screening, to biomarker identification and companion diagnostic development.

Transaction Terms

Under the terms of the agreement, Invitae will acquire ArcherDX for upfront consideration consisting of 30 million shares of Invitae common stock and $325 million in cash, plus up to an additional 27 million shares of Invitae common stock payable in connection with the achievement of certain milestones, for an overall transaction valued at approximately $1.4 billion. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in several months, subject to customary closing conditions including approval by the stockholders of Invitae and ArcherDX.

Financing Activities

In connection with the proposed combination, Invitae has arranged a strategic financing with over $400 million in financing commitments from a premier syndicate of life sciences investors, led by Perceptive Advisors. Invitae has entered into a definitive agreement to sell $275 million in common stock in a private placement at a price of $16.85 per share. The private placement is being supported by key existing investors in Invitae and Archer, including Casdin Capital, Deerfield Management, Driehaus Capital Management, Farallon, PBM Capital, Perceptive Advisors, Redmile Group, Rock Springs Capital, Soleus Capital, and one additional institutional investor. The placement is expected to close concurrently with the proposed combination, subject to the satisfaction of customary closing conditions. Invitae has also entered into a fully committed credit facility for up to $200 million with Perceptive Credit Opportunities Funds, subject to certain customary closing conditions.
Since the filing of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, Invitae has sold under its ATM facility approximately 2.6 million shares of common stock for aggregate gross proceeds of $46 million at an average price of $17.59 per share.
Invitae’s current expectations regarding its cash at transaction close would be approximately $425 million and its annualized near-term forward cash burn is expected to be approximately $130 million.

Advisors

Perella Weinberg Partners served as lead financial advisor to Invitae in connection with the business combination and Cowen served as co-financial advisor. Cowen served as lead-placement agent to Invitae for the private placement and Perella Weinberg Partners served as co-placement agent; Cowen served as exclusive financial advisor to Invitae in connection with the senior secured term loan facility. Evercore and J.P. Morgan Securities LLC acted as financial advisors to Archer.

Webcast

Management will host a conference call and webcast today at 5:00 a.m. PT / 6:00 a.m. MT / 8:00 a.m. ET to discuss the transaction. The dial-in numbers for the conference call are (866) 324-3683 for domestic callers and (509) 844-0959 for international callers, and the reservation number for both is 7097864. Please note, after dialing in, you will be prompted to enter the Conference ID and then the pound “#” sign to enter the call. Following prepared remarks, management will respond to questions from analysts, subject to time limitations.
The live webcast of the call and slide deck may be accessed by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

About Invitae

Invitae Corporation (NYSE: NVTA) is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae’s goal is to aggregate the world’s genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company’s website at invitae.com.

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our ArcherDX® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services with the goal to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our research product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

Safe Harbor Statement

This press release contains statements, including statements regarding the proposed acquisition of ArcherDX, Inc. (“Archer”) by Invitae Corporation (“Invitae”) that are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate” or other comparable terms. All statements other than statements of historical facts included in this presentation regarding strategies, synergies, prospects, financial results, operations, costs, plans, objectives, and the proposed acquisition of Archer by Invitae are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding expected future operating results, including cash at closing and annualized forward cash burn, drivers of future value, future products and services and customers served, regulatory submissions, anticipated results of product development efforts, potential addressable markets, the impact of Covid-19, the anticipated benefits of the proposed acquisition of Archer, including expected synergies, opportunities, product offerings, and financial and other impacts, the transaction structure and financing plans, and the expected timing of completion of the proposed transaction. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: the ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; the ability to meet demand for our products and services; the availability and sufficiency of reimbursement; the amount and nature of competition; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the impact of Covid-19 on the business of Invitae and Archer; Invitae’s ability to manage its growth effectively; the ability of Invitae and Archer to successfully develop new products and services; the ability to effectively utilize strategic partnerships and acquisitions; the ability of Invitae and Archer to obtain and maintain regulatory approvals and comply with applicable regulations; the ability of Invitae and Archer to obtain the required regulatory approvals for the proposed merger and the approval of Invitae’s and Archer’s stockholders, and to satisfy the other conditions to the closing of the acquisition and related financing transactions on a timely basis or at all; the occurrence of events that may give rise to a right of one or both of Invitae and Archer to terminate the merger agreement; negative effects of the announcement or the consummation of the acquisition on the market price of Invitae’s common stock and/or on the companies’ respective businesses, financial conditions, results of operations and financial performance; significant transaction costs and/or unknown liabilities; the possibility that the anticipated benefits from the proposed acquisition of Archer cannot be realized in full or at all or may take longer to realize than expected; risks associated with contracts containing consent and/or other provisions that may be triggered by the proposed acquisition of Archer; risks associated with transaction-related litigation; the possibility that costs or difficulties related to the integration of Archer’s operations with those of Invitae will be greater than expected; the ability of companies individually and the combined company to retain and hire key personnel; Invitae’s failure to manage growth effectively; Invitae’s need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; Invitae’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to Invitae’s business, and the risks and uncertainties set forth in Invitae’s reports on Forms 10-K, 10-Q and 8-K filed with or furnished to the Securities and Exchange Commission (the “SEC”) and other written statements made by Invitae from time to time. There can be no assurance that the proposed acquisition of Archer will in fact be consummated in the manner described or at all. Forward -looking statements speak only as of the date hereof, and Invitae disclaims any obligation to update any forward-looking statements.

NOTE: Invitae and the Invitae logo are trademarks of Invitae Corporation. All other trademarks and service marks are the property of their respective owners.

Additional Information and Where to Find It

In connection with the proposed transaction, Invitae will file with the SEC a registration statement on Form S-4, which will include a document that serves as a proxy statement/prospectus of Invitae (the “proxy statement/prospectus”), and will file other documents regarding the proposed transaction with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. A definitive proxy statement/prospectus will be sent to Invitae’s stockholders when it becomes available. Investors and security holders will be able to obtain the registration statement and the proxy statement/prospectus free of charge from the SEC’s website or from Invitae when it becomes available. The documents filed by Invitae with the SEC may be obtained free of charge at Invitae’s website at www.invitae.com or at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge from Invitae by requesting them by mail at Invitae Corporation, 1400 16th Street, San Francisco, California 94103, or by telephone at (415) 374-7782.

Participants in the Solicitation

Invitae and its directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Invitae’s directors and executive officers is available in Invitae’s proxy statement dated April 29, 2020 for its 2020 Annual Meeting of Stockholders. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the registration statement, the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. Stockholders, potential investors and other readers should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from Invitae as indicated above.

No Offer or Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Non-GAAP Financial Measures

Cash burn is a non-GAAP measure, is not based on any standardized methodology prescribed by GAAP and is not necessarily comparable to similarly-titled measures presented by other companies. A limitation of using cash burn is that it does not represent the total change in cash, cash equivalents, and restricted cash for a period because it excludes cash provided by or used for other operating, investing or financing activities. Management accounts for this limitation by providing information about Invitae’s historical operating, investing and financing activities in the statements of cash flows in the consolidated financial statements in its most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and by presenting net cash provided by (used in) operating, investing and financing activities as well as the net increase or decrease in cash, cash equivalents and restricted cash in its reconciliation of cash burn with such financial statements.

Cash burn is calculated as net increase or decrease in cash and cash equivalents and restricted cash less (a) changes in marketable securities, (b) cash received from equity and debt financings, (c) cash received from exercises of warrants, (d) cash payments made for business acquisitions, and (e) changes in unrealized gains and losses on marketable securities. A reconciliation to GAAP has not been provided as the reconciliation could not reasonably be estimated.
Source: Invitae Corporation

Contact for Invitae:

Laura D’Angelo
ir@invitae.com
(628) 213-3369

Contact for ArcherDX:

Andrea N. Flynn, Ph.D.
Investor Relations & Corporate Communications
ir@archerdx.com

###

ArcherDX Enters Collaboration with Bristol Myers Squibb to Apply Personalized Cancer Monitoring (PCM™) to Clinical Research

Aims to Inform use of Minimal Residual Disease (MRD) Monitoring in Clinical Trial Protocols and Future Therapy Optimization

BOULDER, Colo., June 18, 2020 /PRNewswire/ – ArcherDX, Inc. today announced it is entering into a collaboration with Bristol Myers Squibb (BMS) to utilize Personalized Cancer Monitoring (PCM™) assays to understand the potential benefits of minimal residual disease (MRD) detection in cancer patients treated with immunotherapy. PCM provides tumor-informed longitudinal analysis of circulating tumor DNA (ctDNA) found in patient blood where the quantity of ctDNA is a predictor of disease stage and burden, and achieves accuracy at low limits of detection by focusing the ctDNA analysis on known patient-specific mutations found in the tumor tissue. ArcherDX and BMS will evaluate the clinical samples from cancer patient cohorts with the goal of advancing the use of MRD detection or ctDNA clearance to potentially inform future therapy selection and/or optimization.

“Collaborating with BMS, a leader in oncology, is a significant step toward accomplishing our common goal of improving patient outcomes. We are delighted BMS chose to leverage our Personalized Cancer Monitoring assays for clinical research aimed at expanding precision oncology into early-stage cancers, when the cancer is typically easier to cure compared to late-stage cancers,” said Jason Myers, Chief Executive Officer and co-founder of ArcherDX. “This collaboration further underscores our intention to facilitate real-time monitoring of ctDNA during and after therapy with personalized, decentralized assays that can be distributed across the globe and could potentially optimize the use of current and future cancer therapies.”

ArcherDX’s PCM development program is being advanced by ArcherDX and is supported by a collaboration led by Professor Charles Swanton of UCL and the Francis Crick Institute to detect evidence of disease progression in lung cancer patients from cell-free ctDNA as part of the Cancer Research UK-funded UCL-sponsored TRACERx study.[1] PCM applies ArcherDX’s proprietary Anchored Multiplex PCR (AMP™) technology to accurately detect exceedingly low levels of cancer-derived DNA from patient blood.

About Personalized Cancer Monitoring

PCM is a patient-specific assay for monitoring residual disease, disease recurrence and progression of cancer. At initial diagnosis, exome sequencing of the surgically removed tumor or a tumor biopsy is used to identify patient-specific cancer mutations. A patient-specific assay is delivered to the laboratory affiliated with the patient’s care team. Clinicians use the personalized assay to measure ctDNA taken from non-invasive peripheral blood draws at specified intervals, producing a quantitative longitudinal view of the cancer’s evolution.

PCM is currently available and sold under a research use only (RUO) designation and is not yet approved for broad clinical use. Once it receives regulatory approval, PCM could ultimately expand the use of precision oncology to early-stage cancers, potentially providing faster diagnostic solutions in the future at local and regional laboratories inside and outside the U.S.

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM™) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

[1] TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research program is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analyzing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.

Forward-Looking Statement

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “aim,” “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding the increased use of PCM following regulatory approval. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

ArcherDX Contact

Andrea N. Flynn, Ph.D.

Investor Relations & Corporate Communications

ir@archerdx.com

  1. Chris Abbosh et al. Phylogenetic tracking and minimal residual disease detection using ctDNA in early-stage NSCLC: A lung TRACERx study. AACR Annual Meeting 2020 Virtual Meeting I, CT023

ArcherDX Announces Strategic Collaboration with AstraZeneca to Develop Personalized Cancer Monitoring (PCM) Assays for Minimal Residual Disease (MRD)

AstraZeneca to Leverage ArcherDX’s PCM Liquid Biopsy Technology to Facilitate Multiple Clinical Trials for Early-Stage Non-Small Cell Lung Cancer Therapies

BOULDER, Colo., May 26, 2020 /PRNewswire/ — ArcherDX, Inc., today announced a strategic collaboration with AstraZeneca to develop assays to support multiple planned Phase 3 clinical trials for AstraZeneca’s targeted immuno-oncology therapeutics. 

Under the terms of the agreement, ArcherDX will perform Whole Exome Sequencing (WES) of resected non-small cell lung cancer (NSCLC) patient samples and generate patient-specific circulating tumor DNA (ctDNA) assays. ArcherDX plans to leverage the PCM assays to develop companion diagnostics (CDx) for AstraZeneca’s associated therapies, and together, the companies plan to seek global regulatory approval if the Phase 3 clinical trials are completed successfully. The assays are currently for investigational use only. 

“While there has been progress in improving adoption of precision oncology for patients with late-stage cancers, there is a pressing need to accelerate access to precision oncology for all patients diagnosed with cancer regardless of the stage or location of the care setting,” said Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX. “AstraZeneca shares this critical mission, and we are pleased to partner with them in the development of biomarker-driven therapies and the expansion of personalized cancer monitoring for all patients. Because Archer’s distributed model does not require a centralized laboratory, we intend to distribute regulated products globally. We believe our approach will revolutionize how cancer is managed by measuring cancer progression based on the genomic tumor profile of the individual cancer regardless of where the patient receives care.” 

ArcherDX’s Personalized Cancer Monitoring (PCM) development program is being developed by ArcherDX and is supported by a collaboration led by Professor Charles Swanton of UCL and the Francis Crick Institute to detect evidence of disease progression in lung cancer patients from cell-free ctDNA as part of the Cancer Research UK-funded UCL-sponsored TRACERx study.[1] PCM applies ArcherDX’s proprietary Anchored Multiplex PCR (AMP™) technology to accurately detect exceedingly low levels of cancer-derived DNA from patient blood.

“MERMAID-1 is a novel randomized trial using ctDNA to identify patients at high risk of recurrence after surgery who may benefit from intervention with immunotherapy,” said Charles Swanton, M.D., Ph.D., UCL and the Francis Crick Institute, lead researcher of the TRACERx study. “We hope this approach will lead to better patient outcomes by intensifying treatment in patients most likely to relapse, while avoiding additional chemotherapy after surgery when not needed.”

José Baselga, Executive Vice President of Oncology R&D at AstraZeneca, said, “While detecting and monitoring for minimal residual disease has proven challenging in solid tumors, the MERMAID-1 trial and this partnership stand to break new ground in lung cancer. This innovative endeavor is reflective of our strategy to improve cancer outcomes by treating patients as early as possible. It is in this early setting that the chance of cure is higher and identifying personalized, effective treatments could increase survival and improve quality of life.”

The master collaboration agreement also allows for expansion into additional disease indications and therapeutic categories.

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

[1] TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analyzing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.

Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding ArcherDX’s plans to leverage the PCM assays to develop CDx for AstraZeneca’s associated therapies; the companies’ plans to seek global regulatory approval; and the impact of ArcherDX’s platform and decentralized approach on how cancer is managed. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

ArcherDX Contact
Andrea N. Flynn, Ph.D.
Investor Relations & Corporate Communications
ir@archerdx.com

ArcherDX Receives Breakthrough Device Designation to Detect NTRK Gene Fusions

BOULDER, Colo., May 19, 2020 /PRNewswire/ — ArcherDX, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next-generation sequencing (NGS) device under development as a companion diagnostic (CDx) to detect neurotrophic receptor tyrosine kinase (NTRK) gene fusions that lead to the formation and growth of cancer. ArcherDX’s NGS technology utilizes proprietary Anchored Multiplex PCR (AMP™) chemistry that captures DNA, RNA or ctDNA from both blood and tissue samples regardless of the location of the tumor.

ArcherDX is developing and pursuing regulatory clearances for its NGS diagnostic to help solve for the underutilization of targeted therapies. ArcherDX’s technology is designed to enable the use of the diagnostic in community and regional settings where the lack of infrastructure and expertise to implement sophisticated genomic analysis can limit a clinician’s ability to optimize therapy for patients through diagnosis, prognosis and therapy selection.  

“NTRK gene fusions are notoriously difficult to detect in cancer.  ArcherDX’s next-generation sequencing technology uses RNA to provide sensitive NTRK fusion detection without requiring prior knowledge of fusion partners for any solid tumor,i” said Jason Myers, Ph.D., Chief Executive Officer and co-founder of ArcherDX. “Our goal is to develop products to help clinicians receive the right information at the right time to make the right treatment decision.”

ArcherDX recently announced a collaboration to develop an NGS-based CDx for a TRK inhibitor. 

The Breakthrough Devices Program is a voluntary program intended to expedite the review, development and assessment of certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.  

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

Forward-Looking Statement

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding ArcherDX’s goals and strategic plans. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

ArcherDX Contact
Andrea N. Flynn, Ph.D.
Investor Relations & Corporate Communications
ir@archerdx.com

i. Hsiao, S., Zehir, A., Sireco, A. and Aisner, D. Detection of Tumor NTRK Gene Fusions to Identify Patients Who May Benefit from Tyrosine Kinase (TRK) Inhibitor Therapy. The Journal of Molecular Diagnostics. 2019: 21(4):553-571.

Bayer and ArcherDX Announce Global Collaboration to Develop Next-Generation Sequencing (NGS)-based Companion Diagnostic (CDx) for VITRAKVI® (larotrectinib)

Collaboration will focus on development of a companion diagnostic (CDx) for Vitrakvi®, the first-in-class tyrosine kinase (TRK) inhibitor approved in the U.S. and Europe for adult pediatric patients with TRK fusion cancer across all solid tumors. Vitrakvi has the largest and longest-term data set in TRK fusion cancer.*

Goal is to advance broad patient access to comprehensive genomic testing through kit-based CDx that can be deployed locally at the site of care in line with Bayer’s commitment to advancing precision oncolytics.

Boulder, Colorado, USA / Berlin, May 14, 2020 – Bayer and ArcherDX, Inc. today announced a global collaboration for the development and commercialization of a next-generation sequencing (NGS)-based companion diagnostic (CDx) for Vitrakvi® (larotrectinib). The primary objective of the collaboration is to broaden patient access to comprehensive genomic testing inclusive of neurotrophic receptor tyrosine kinase 1 (NTRK1), NTRK2 and NTRK3 gene fusions and to help improve identification of appropriate treatment options for patients with TRK fusion cancer which can lead to meaningful treatment options.

Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1

Genomic cancer testing helps detect changes in a tumor’s DNA, called genomic profiling, that can determine how the cancer behaves and why it grows or spreads.2 Almost 50 percent of patients who undergo genomic cancer testing may have actionable genomic alterations, meaning the alterations can be matched to treatments that have been approved or are in clinical trials.3,4 Genomic cancer testing has already impacted patient cancer care in both common and rare malignancies. This has allowed for the identification of personalized treatment options.5 However, studies show that only a small percentage of cancer patients undergo such testing.5 It is therefore critical that testing becomes part of routine clinical practice to help guide treatment choice.

“In order to help more patients to benefit from Vitrakvi, a treatment with efficacy in TRK fusion cancer, broader access to high quality testing via next-generation sequencing is of key importance,” said Robert LaCaze, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. “The collaboration with ArcherDX perfectly complements Bayer’s CDx strategy and fits our ambition to further advance the field of genomic testing and personalized treatment, providing the right treatment to the right patient for patients with cancer.”

“Barriers currently exist that inhibit the broad adoption of genomic testing to inform  treatment decisions. A kit-based CDx that is tumor agnostic and detects all NTRK gene fusions will enable high-quality genomic testing to be deployed in regional and community settings, where 85 percent of cancer patients receive care.6 For these patients, our technology provides RNA-based profiling for the detection of actionable fusions across known and novel NTRK fusion partners,” said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. “We are pleased to collaborate with Bayer to address their medical need and accelerate access to therapy.”

NGS-based CDx tests aim to unlock molecular information from each patient’s tumor genome to guide treatment decisions for cancer therapies. ArcherDX is developing and pursuing regulatory clearances for an in vitro diagnostic (IVD), a comprehensive NGS-based therapy selection product that utilizes Archer’s proprietary Anchored Multiplex PCR (AMP™) technology to measure clinically relevant genomic mutations for tumor profiling and CDx from both tissue and blood.

ArcherDX and Bayer are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2, NTRK3 for Vitrakvi and plan to seek approval in different markets, including the European Union (EU), U.S. and Japan. The CDx version of this panel will allow local laboratories to provide referring physicians with potentially actionable genomic information, so that appropriate patients can be matched to specific therapeutic options based on their genomic findings.

The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration. Financial terms of the agreement were not disclosed.

About Vitrakvi® (larotrectinib) 

Vitrakvi® (larotrectinib) is a first-in-class TRK inhibitor for TRK fusion cancer across solid tumors. Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1

Vitrakvi is approved in several markets, including the U.S., EU, Canada and Brazil.

TRK fusion cancer is rare overall, affecting no more than a few thousand patients across the U.S. and Europe. It affects both children and adults and occurs in varying frequencies across various solid tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body.

Important Safety Information for VITRAKVI® (larotrectinib)

Neurotoxicity: Among the 176 patients who received VITRAKVI, neurologic adverse reactions of any grade occurred in 53% of patients, including Grade 3 and Grade 4 neurologic adverse reactions in 6% and 0.6% of patients, respectively. The majority (65%) of neurologic adverse reactions occurred within the first three months of treatment (range 1 day to 2.2 years). Grade 3 neurologic adverse reactions included delirium (2%), dysarthria (1%), dizziness (1%), gait disturbance (1%), and paresthesia (1%). Grade 4 encephalopathy (0.6%) occurred in a single patient. Neurologic adverse reactions leading to dose modification included dizziness (3%), gait disturbance (1%), delirium (1%), memory impairment (1%), and tremor (1%).1

Advise patients and caretakers of these risks with VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dose when resumed.1

Hepatotoxicity: Among the 176 patients who received VITRAKVI, increased transaminases of any grade occurred in 45%, including Grade 3 increased AST or ALT in 6% of patients. One patient (0.6%) experienced Grade 4 increased ALT. The median time to onset of increased AST was 2 months (range: 1 month to 2.6 years). The median time to onset of increased ALT was 2 months (range: 1 month to 1.1 years). Increased AST and ALT leading to dose modifications occurred in 4% and 6% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 2% of patients.1

Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed.1

Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman. Larotrectinib resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily.1

Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the final dose of VITRAKVI.1

Most Common Adverse Reactions (≥20%): The most common adverse reactions (≥20%) were: increased ALT (45%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%).1

Drug Interactions: Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors (including grapefruit or grapefruit juice), strong CYP3A4 inducers (including St. John’s wort), or sensitive CYP3A4 substrates. If coadministration of strong CYP3A4 inhibitors or inducers cannot be avoided, modify the VITRAKVI dose as recommended. If coadministration of sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs.1

Lactation: Advise women not to breastfeed during treatment with VITRAKVI and for 1 week after the final dose.1

Please see the full Prescribing Information for VITRAKVI® (larotrectinib).

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

© 2020 Bayer

BAYER, the Bayer Cross and VITRAKVI are registered trademarks of Bayer.

Contact Bayer
Rose Talarico, 862-404-5302
Email: rose.talarico@bayer.com

Contact ArcherDX
Andrea N. Flynn, Ph.D.
Email: ir@archerdx.com

Bayer Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

ArcherDX Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding ArcherDX’s goals and strategic plans. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

*Included 121 patients with 93 patients evaluable by blinded independent review committee (BIRC) based on July 2018 data cuto­ff (17.7 months of follow-up)

  1. Vitrakvi [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2019.
  2. Cancer Treatment Centers of America. Advanced genomic testing. https://www.cancercenter.com/treatment-options/precision-medicine/advanced-genomic-testing. Accessed March 2020.
  3. Boland GM, Piha-Paul SA, Subbiah V, et al. Clinical next generation sequencing to identify actionable aberrations in a phase I program. Oncotarget. 2015;6(24):20099-20110.
  4. Massard C, Michiels S, Ferte C, et al. High-throughput genomics and clinical outcome in hard-to-treat advanced cancers: results of the MOSCATO 01 trial. Cancer Discov. 2017;7(6):586-595.
  5. Malone, E.R., Oliva, M., Sabatini, P.J.B., et al. Molecular profiling for precision cancer therapies. Genome Med. 2020;12(8). https://doi.org/10.1186/s13073-019-0703-1
  6. El-Deiry, W., et al. The current state of molecular testing in the treatment of patients with solid tumors, 2019. Cancer J Clin. 2019;69(4): 305-343.

ArcherDX Appoints Jason Ryan to Board of Directors

BOULDER, Colo., May 7, 2020 /PRNewswire/ — ArcherDX, Inc. today announced the appointment of Jason Ryan, Chief Operating and Financial Officer at Magenta Therapeutics and former Chief Financial Officer at Foundation Medicine, to the company’s Board of Directors and as the Chair of the Audit Committee.

“We are thrilled to welcome Jason to our Board of Directors. As a leader with experience overseeing commercial growth and financial operations, Jason will augment our experienced leadership team,” said Jason Myers, Ph.D., Chief Executive Officer and co-founder of ArcherDX. “His depth of experience in both diagnostics and therapeutics will be important as we pursue regulatory clearances and approvals for our IVD products that are designed to enable providers to conduct genomic testing at the site of patient care and receive the right information at the right time.”

Jason Ryan joined Magenta in 2019 and is responsible for finance, planning and operations at the company. During his tenure as Chief Financial Officer of Foundation Medicine, he helped lead the company from an early stage private company through its initial public offering and subsequent growth to a global commercial organization that was ultimately sold to Roche for $5.3 billion in 2018. He also worked closely with the company’s commercial leadership through several product launches and was deeply involved in Medicare and commercial payor reimbursement strategy and execution. He began his career at Deloitte & Touche where he earned a CPA. Jason received his B.S. in Economics from Bates College and his MBA from the Babson F.W. Olin Graduate School of Business.

“Jason’s expertise in financial and commercial strategy, building operational infrastructure, and working with private and public investors were instrumental to the tremendous corporate growth we achieved while working together at Foundation Medicine,” said Steve Kafka, Ph.D., Executive Chairman of ArcherDX. “I look forward to working with Jason again to help enable ArcherDX to successfully grow and drive innovation in genomic testing and cancer care.”

“ArcherDX is aiming to address the barriers to precision oncology and to bring precision oncology to all patients, anywhere,” said Jason Ryan. “Democratizing precision oncology requires products that are accurate, personal, actionable and easy to use in local settings. I’m excited to be joining a team that I believe has the technology, experience and drive to deliver on this promise to patients and providers.”

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

Forward-Looking Statement

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding ArcherDX’s goals and strategic plans. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

ArcherDX Contact
Andrea N. Flynn, Ph.D.
Investor Relations & Corporate Communications
ir@archerdx.com

ArcherDX and UCL Present New Minimal Residual Disease Surveillance Data from their Collaboration at 2020 AACR Virtual Annual Meeting

First presentation of the data utilizing ArcherDX’s proprietary Anchored Multiplex PCR (AMP™) technology to generate patient-specific panels to monitor cancer over time and provide insight into the biology behind relapse

BOULDER, Colo. and LONDON, April 28, 2020 /PRNewswire/ — ArcherDX, Inc., UCL and the Francis Crick Institute today announced new data from their research collaboration as part of the Cancer Research UK-funded UCL-sponsored TRACERx study. Based on the on-going collaboration between ArcherDX and UCL, utilizing ArcherDX’s AMPTM technology, the data  demonstrated cancer circulating tumor DNA (ctDNA) monitoring for minimal residual disease (MRD) can detect relapse of non-small cell lung cancer (NSCLC) earlier than standard of care imaging surveillance in some instances. Post-operative timepoints were analyzed from 90 TRACERx patients. In patients whose cancer had relapsed and shed ctDNA, the ctDNA was detected at or before relapse with a median lead-time, or time from ctDNA detection to clinical relapse, of 164 days (range: 6 to 1,022 days) in the TRACERx study tracking a median of 200 variants per patient. Furthermore, in non-relapse patients, the assay demonstrated 99.3% clinical specificity within the research data set. Results from the analytical validation of a 50-variant version of the research assay demonstrated 100% specificity with detection down to 0.003% variant fractions at high cell-free (cfDNA) input levels.[i]

With more sensitive detection of ctDNA for MRD as a biomarker, it is possible for adjuvant clinical trials to be conducted in smaller and more relevant settings by only escalating therapy in patients who are set to relapse, thereby potentially reducing trial size, cost and time. The full results of the analysis will now be presented today at 2:30 p.m. ET during the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting (abstract #2025).[i]

“Specificity is a critical and under-appreciated requisite of frequent disease monitoring,” said Christopher Abbosh, M.D., Principal Clinical Fellow, UCL. “Data from a 50-variant version of the research assay demonstrates a variant detection limit of 0.003% at high cfDNA input levels while maintaining 100% variant analytical specificity. Together, with our collaborators, we aim to establish an MRD approach to treating early-stage NSCLC in order to determine which patients are likely to relapse and overcome challenges associated with conventional adjuvant therapy trial design. We believe this approach will provide an opportunity to expand precision oncology into early-stage cancer, when the cancer is typically easier to cure.”

ArcherDX’s Personalized Cancer Monitoring (PCM) development program is being developed by ArcherDX and is supported by a collaboration led by Professor Charles Swanton of UCL and the Francis Crick Institute to detect evidence of disease progression in lung cancer patients from cell-free ctDNA as part of the Cancer Research UK-funded UCL-sponsored TRACERx study. PCM applies Archer’s proprietary Anchored Multiplex PCR (AMP™) technology to accurately detect exceedingly low levels of cancer-derived DNA from patient blood.

“There remains a stark unmet need to improve the current adjuvant standard of care and outcomes in patients with solid tumors,” said Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX. “Key to reducing patient burden in cancer treatment is a minimally invasive assay that enables tracking disease recurrence at the earliest possible time point directly at the patient’s care setting. We are thrilled to collaborate with the UCL team, which aligns closely with ArcherDX’s mission to bring the right test to the right patient at the right time.”

Lung cancer is one of the most common types of cancer worldwide and a leading cause of cancer-related death.[ii] NSCLC is the most common type of lung cancer[iii] and has a complex genomic landscape.[iv]

About TRACERx Study

TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analysing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

About UCL – London’s Global University

UCL is a diverse community with the freedom to challenge and think differently.

Our community of more than 41,500 students from 150 countries and over 12,500 staff pursues academic excellence, breaks boundaries and makes a positive impact on real world problems.

We are consistently ranked among the top 10 universities in the world and are one of only a handful of institutions rated as having the strongest academic reputation and the broadest research impact.

We have a progressive and integrated approach to our teaching and research – championing innovation, creativity and cross-disciplinary working. We teach our students how to think, not what to think, and see them as partners, collaborators and contributors.  

For almost 200 years, we are proud to have opened higher education to students from a wide range of backgrounds and to change the way we create and share knowledge.

We were the first in England to welcome women to university education and that courageous attitude and disruptive spirit is still alive today. We are UCL.

www.ucl.ac.uk | Follow @uclnews on Twitter | Watch our YouTube channel | Listen to UCL podcasts on SoundCloud | Find out what’s on at UCL Minds | #MadeAtUCL

About The Francis Crick Institute

The Francis Crick Institute is a biomedical discovery institute dedicated to understanding the fundamental biology underlying health and disease. Its work is helping to understand why disease develops and to translate discoveries into new ways to prevent, diagnose and treat illnesses such as cancer, heart disease, stroke, infections, and neurodegenerative diseases.

An independent organisation, its founding partners are the Medical Research Council (MRC), Cancer Research UK, Wellcome, UCL (University College London), Imperial College London and King’s College London.

The Crick was formed in 2015, and in 2016 it moved into a brand new state-of-the-art building in central London which brings together 1500 scientists and support staff working collaboratively across disciplines, making it the biggest biomedical research facility under a single roof in Europe.  http://crick.ac.uk/

About Cancer Research UK

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public. Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.

Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years. Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.

Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured. For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “aim,” “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding the impact of the collaboration with UCL, the goal to establish and the expected impact of the MRD approach to treating early-stage NSCLC on precision oncology. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

ArcherDX Contact
Andrea N. Flynn, Ph.D.
Investor Relations & Corporate Communications
ir@archerdx.com

[i] Abbosh, C., et al. Phylogenetic tracking and minimal residual disease detection using ctDNA in early-stage NSCLC: A lung TRACERx study. Presented at the 2020 American Association for Cancer Research: April 28, 2020.
[ii] World Health Organization. 2018 Cancer Statistics. https://www.who.int/news-room/fact-sheets/detail/cancer Accessed April 2020.
[iii] American Society of Clinical Oncology. Lung Cancer – Non-Small Cell Statistics. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics Accessed April 2020.

Bruin, E., McGranahan, N., Swanton, C. Analysis of intratumor heterogeneity unravels lung cancer evolution. Mol Cell Oncol. 2015;2(3): e985549.

Letter from Chief Executive Officer and Co-founder, Jason Myers

April 17, 2020

Over the course of the last several weeks, our lives have been disrupted in ways we would not have predicted. COVID-19 continues to have an impact on communities, patients, co-workers, partners and customers and will for some time. Ensuring the health and safety of our employees and patients is paramount, as is our mission to deliver best-in-class products to make precision oncology available for all.

As we face these challenges together, I have received countless messages of support that have made me realize quite a few things, including the need to make certain we respond to this situation in a way that is aligned with our Company values of Accountability, Caring, Grit, Truth and Urgency. While we talk about our values on a regular basis, never have they been more important than they are today. For me, the thing that stands above all else is how we treat one another.

The impact across the globe is enormous. In light of the situation, ArcherDX sites remain operational, and we are continuing to provide our products and services for partners, patients and providers. Our commitments are critically important to us, as is the health and safety of our team.

As a critical workplace, ArcherDX will continue to perform service, manufacturing and distribution operations. We believe we are taking appropriate steps to minimize risk to our team and have implemented proactive measures, while continuing to assess if additional mitigations are required.

It is important that we remain steadfast in this journey while caring for ourselves and our families.

Wishing you and your families health and safety.

Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX

ArcherDX and UCL to Present Data from their Collaboration at the 2020 AACR Virtual Annual Meeting

BOULDER, Colo., April 15, 2020 /PRNewswire/ — ArcherDX, Inc., today announced that new data from its research collaboration with UCL and the Francis Crick Institute as part of the Cancer Research UK-funded UCL-sponsored TRACERx study was chosen to be presented by UCL on Tuesday, April 28 at 2:15 p.m. ET during the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting. The TRACERx study, a translational research program taking place over nine years, follows patients with lung cancer from diagnosis to either disease relapse or cure after surgery, tracking and analyzing how their cancer develops.

“Clinicians are eager to expand precision oncology into early-stage cancer, when the cancer is typically easier to cure compared to late-stage cancer. Current monitoring methods, such as diagnostic imaging and cancer antigen tests, lack resolution and accuracy needed to monitor early-stage disease. Our technology allows for clinicians to use the assays in local labs and maintain control of the data,” said Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX. “This collaboration with UCL and the Francis Crick Institute aims to detect minimal residual disease, earlier by tracking personalized, patient-specific mutations.”

As part of an ongoing collaboration, TRACERx1 investigators, led by Professor Charles Swanton, Group Leader, UCL and the Francis Crick Institute, and Dr. Christopher Abbosh, Principal Clinical Fellow, UCL, are utilizing ArcherDX’s technology to detect low-volume minimal residual disease at high levels of sensitivity to achieve TRACERx’s goal of a more personalized approach to developing cancer treatments.

Oral Presentation Details

The virtual meeting is free and available to anyone by registering at aacr.org.

 

Presentation Title:

Phylogenetic tracking and minimal residual disease detection using ctDNA in early-stage NSCLC: A lung TRACERx study

Presenter:

Christopher Abbosh, M.D., Principal Clinical Fellow, University College London

Session Title:

Early Detection and ctDNA

Session Date and Time:

Tuesday, April 28 at 2:15 p.m. ET

Abstract Number:

2025

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
[1] *TRACERx (Tracking Cancer Evolution through therapy (Rx)) is the single biggest investment in lung cancer research by Cancer Research UK. We believe the translational programme is the first study to look at the evolution of cancer in real time and immense detail. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.

About UCL – London’s Global University

UCL is a diverse community with the freedom to challenge and think differently.
Our community of more than 41,500 students from 150 countries and over 12,500 staff pursues academic excellence, breaks boundaries and makes a positive impact on real world problems.
We are consistently ranked among the top 10 universities in the world and are one of only a handful of institutions rated as having the strongest academic reputation and the broadest research impact.
We have a progressive and integrated approach to our teaching and research – championing innovation, creativity and cross-disciplinary working. We teach our students how to think, not what to think, and see them as partners, collaborators and contributors.
For almost 200 years, we are proud to have opened higher education to students from a wide range of backgrounds and to change the way we create and share knowledge.
We were the first in England to welcome women to university education and that courageous attitude and disruptive spirit is still alive today. We are UCL.

www.ucl.ac.uk| Follow @uclnews on Twitter | Watch our YouTube channel | Listen to UCL podcasts on SoundCloud | Find out what’s on at UCL Minds | #MadeAtUCL

About The Francis Crick Institute

The Francis Crick Institute is a biomedical discovery institute dedicated to understanding the fundamental biology underlying health and disease. Its work is helping to understand why disease develops and to translate discoveries into new ways to prevent, diagnose and treat illnesses such as cancer, heart disease, stroke, infections, and neurodegenerative diseases.
An independent organisation, its founding partners are the Medical Research Council (MRC), Cancer Research UK, Wellcome, UCL (University College London), Imperial College London and King’s College London.
The Crick was formed in 2015, and in 2016 it moved into a brand new state-of-the-art building in central London which brings together 1500 scientists and support staff working collaboratively across disciplines, making it the biggest biomedical research facility under a single roof in Europe. http://crick.ac.uk/

About Cancer Research UK

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public. Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years. Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured. For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding the goals and plans of the trial. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

ArcherDX Contact

Andrea N. Flynn, Ph.D.
Investor Relations & Corporate Communications
ir@archerdx.com

ArcherDX Receives Approval for Archer®MET Companion Diagnostic for TEPMETKO® (Tepotinib) in Advanced Non-Small Cell Lung Cancer in Japan

BOULDER, Colo., March 25, 2020/PRNewswire/ — ArcherDX, Inc., today announced that its ArcherMET companion diagnostic (CDx) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical Medical Devices Agency (PMDA) to detect MET exon 14 (METex14) skipping alterations in tissue (RNA) and liquid biopsy (ctDNA) from patients with advanced non-small cell lung cancer (NSCLC) for consideration for treatment with Merck KGaA, Darmstadt, Germany’s oral MET inhibitor, TEPMETKO®* (tepotinib). ArcherMET is the first and only CDx to be approved for the detection of MET gene alterations and it allows for testing of blood and tissue samples. TEPMETKO is the first approved MET inhibitor in Japan, and is indicated for the treatment of unresectable, advanced or recurrent non-small cell lung cancer with METex14 skipping alterations. TEPMETKO is administered orally once daily. Please see recent news about TEPMETKO here.

Merck KGaA, Darmstadt, Germany launched a strategic partnership with ArcherDX in 2018 to develop a CDx featuring both liquid and tissue biopsy capabilities, including a program to identify METex14 skipping alterations among patients with advanced NSCLC.

“We’re delighted that the Japan approval of ArcherMET as a companion diagnostic for TEPMETKO means NSCLC patients will have access to Merck KGaA, Darmstadt, Germany’s targeted therapy with demonstrated efficacy,” said Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX. “This approval is the most recent highlight from our ongoing partnership with Merck KGaA, Darmstadt, Germany, and demonstrates our ability to deliver highly accurate and precise companion diagnostics that enable our global partners to accelerate access to therapies for patients in need and democratize personalized medicine.”

“With the approval of TEPMETKO and its companion diagnostic, ArcherMET in Japan, NSCLC patients harboring MET exon 14 skipping alterations can now be identified and treated with a targeted approach and precision that was not previously possible,” said Zhen Su, M.D., MBA, Senior Vice President & Head of Global Franchise Oncology, Merck KGaA, Darmstadt, Germany. “We are excited that through our partnership with ArcherDX, we are able to address this unmet medical need with a precision approach and deliver important progress for patients living with this aggressive form of lung cancer.”

Lung cancer is one of the most common types of cancer worldwide, with approximately 2 million cases diagnosed in 2018.[i] It is also the second most common type of cancer in Japan. Alterations of the MET signaling pathway, such as METex14 skipping alterations, are found in various cancer types, including 3% to 5% of NSCLC cases, and correlate with aggressive tumor behavior and poor clinical prognosis.[ii],[iii],[iv]
*The brand name TEPMETKO® is not approved for use outside of Japan.

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. STRATAFIDE™ and Personalized Cancer Monitoring (PCM) are IVD products currently in development and have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.newarchdxdev.wpengine.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding the impact of the Japan approval of ArcherMET as a companion diagnostic for TEPMETKO on patients. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

ArcherDX Contact

Andrea N. Flynn, Ph.D.
Investor Relations & Corporate Communications
ir@archerdx.com

ArcherDX Japan Contact

Reiko Nishiguchi
japan@archerdx.com

  1. Bray F, et al. CA Cancer J Clin. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. 2018;68(6):394–424. https://doi.org/10.3322/caac.21492 PMID:30207593
  2. Reungwetwattana T, et al. Lung Cancer 2017;103:27-37.
  3. Mo HN, et al. Chronic Dis Transl Med 2017; 3(3):148-153..
  4. Lutterbach B, et al. Cancer Res 2007;67:2081–8.
  5. 2019;11(9):1309.