Companion Diagnostics and ArcherDX


Partner with ArcherDX to develop and commercialize an IUO companion diagnostic test for your clinical trial program. We provide custom target enrichment assays to detect all major types of mutations across genes relevant to your research from a single sample. Archer’s AMP technology enables highly sensitive NGS-based detection of novel gene fusions, CNVs, SNPs/SNVs and indels from low input FFPE samples. Work with our expert assay designers to develop AMP-based NGS CDx tests to suit your needs. Complete the form below to speak with a member of our CDx team and find out more.


Clinical trials featuring Archer assays

Phase II entrectinib clinical trial, STARTRK-2, NCT02568267

Co-developed with ArcherDX, Ignyta’s NGS-based clinical trial assay supports patient identification and enrollment into its STARTRK-2 clinical trial for entrectinib, a tyrosine kinase inhibitor targeting NTRK1/2/3, ROS1 and ALK.

Sponsor: Ignyta, Inc.
Information provided by (Responsible Party): Ignyta, Inc.
ClinicalTrials.gov Identifier: NCT02568267
First received: October 2, 2015
Last updated: March 18, 2016
Last verified: March 2016
See the STARTRK-2 clinical trial startrktrials.com


Watch the video below to learn more about how Ignyta™ uses Archer™ NGS Assays:

 

Phase 2 entrectinib clinical trial, STARTRK-2

(Studies of Tumor Alterations Responsive to Targeting Receptor Kinases-2)

Participation in the Ignyta STARTRK-2 Phase 2 Clinical Trial of entrectinib will include access to Ignyta’s Trailblaze™ companion diagnostics (CDx) platform— Trailblaze Pharos™ is a multiplex assay for identifying actionable gene rearrangements in solid tumors that can be treated with entrectinib.

Entrectinib (formerly known as RXDX-101) is a potent inhibitor of the tyrosine kinases TrkA (encoded by the gene NTRK1), TrkB (encoded by the gene NTRK2), TrkC (encoded by the gene NTRK3), ROS1 (encoded by the gene ROS1), and ALK (encoded by the gene ALK), with IC50 values for kinase inhibition in the low nanomolar range (1.7, 0.1, 0.1, 0.2, and 1.6 nM, respectively). While these proteins play various roles in normal cellular function, rearrangements in these target kinases have the potential to be oncogenic drivers, they tend to be mutually exclusive, and are present in small percentages in a variety of tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), salivary gland cancer, papillary thyroid cancer, melanoma, and sarcoma.

In the two Phase 1 clinical studies (ALKA-372-001 and STARTRK-1) that have been conducted to determine the Recommended Phase 2 Dose (RP2D) of entrectinib, patients with locally advanced or metastatic solid tumors harboring at least one of the target molecular alterations were enrolled irrespective of tumor type.

  1. Vaishnavi A, et al., TRKing down an old onco-gene in a new era of targeted therapy. Cancer Discov 5:25-34 (2015).


Start a CDx partnership with Archer now

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For Research Use Only. Not for use in diagnostic procedures. For Research Use Only. Not for use in diagnostic procedures.