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. PCM applies ArcherDX’s proprietary Anchored Multiplex PCR (AMP™) technology to accurately detect exceedingly low levels of cancer-derived DNA from patient blood.
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.
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.
 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.
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.
Andrea N. Flynn, Ph.D.
Investor Relations & Corporate Communications