Expanded collaboration aimed at developing FoundationOne CDx as a companion diagnostic for Bristol Myers Squibb’s investigational tyrosine kinase inhibitor, repotrectinib

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer announced today, an expanded collaboration with Bristol Myers Squibb (NYSE: BMY) to develop Foundation Medicine’s tissue-based test, FoundationOne®CDx as a companion diagnostic for Bristol Myers Squibb’s investigational tyrosine kinase inhibitor, repotrectinib.

Repotrectinib is an orally administered TKI (tyrosine kinase inhibitor) being evaluated in an ongoing registrational Phase 1/2 trial called TRIDENT-1 for patients with TKI-naive or TKI-pretreated ROS1+ advanced non-small cell lung cancer (NSCLC) and NTRK+ advanced solid tumors. If the companion diagnostic is approved for these indications, and separately, the therapy is approved, oncologists would be able to use FoundationOne CDx to help identify appropriate patients for treatment with repotrectinib.

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians blood and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Currently, Foundation Medicine is the leader in companion diagnostic approvals with approximately 60% of all companion diagnostic approvals for NGS testing in the U.S.

“We’re proud to broaden our collaboration with Bristol Myers Squibb as they work to bring this exciting investigational therapy to patients living with ROS1 positive non-small cell lung cancer and NTRK positive solid tumors,” said Jason Adams, Vice President of Biopharma Enterprise Partnerships, Foundation Medicine. “This new collaboration builds on our ongoing research-driven partnership and furthers our shared commitment to deliver more treatment options to patients who need them.”

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOne®CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

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