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Merck, Foundation Medicine to Develop Companion Diagnostics for Immunotherapy

NEW YORK (GenomeWeb) – Foundation Medicine has inked a collaboration with Merck to develop companion diagnostic tests for use with Merck's anti-PD-1 immunotherapy drug Keytruda (pembrolizumab).

Under the agreement announced today, the companies plan to develop a pan-cancer CDx to measure microsatellite instability (MSI), CDx tests for tumor mutational burden (TMB), and other novel biomarkers of response.

The CDx tests will use Foundation Medicine's US Food and Drug Administration-approved genomic profiling assay FoundationOne CDx, which looks for genomic alterations in 324 genes associated with cancer growth.

"The addition of MSI and TMB companion diagnostics to FoundationOne CDx reaffirms the validity and clinical utility of these critical immuno-oncology biomarkers, can simplify diagnostic testing through the use of one test that provides physicians with necessary information to both rule in and rule out potential treatment options based on each patient's genomic and biomarker status, and can help accelerate patient access to personalized healthcare," said Melanie Nallicheri, chief business officer and head of biopharma for Foundation Medicine, in a statement.

The collaboration adds to others that Foundation Medicine has signed with pharmaceutical companies, including its partner and investor Roche, Chugai Pharmaceutical (a member of the Roche group), Bristol-Myers Squibb, and Pfizer. The company said earlier this year that it plans to grow its business with biopharmaceutical firms in 2018.