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Foundation Medicine Liquid Biopsy Gets FDA Approval for Multiple Companion Diagnostic Indications

NEW YORK – The US Food and Drug Administration has approved Foundation Medicine's FoundationOne Liquid CDx, a multi-cancer comprehensive liquid-biopsy test, for multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.

The approval is the agency's second for a comprehensive liquid biopsy, following on the heels of a nod earlier this month for Guardant Health's Guardant360 CDx test.

Foundation Medicine, a Roche company, has been offering a laboratory-developed version of the liquid biopsy assay for several years. The company's test is broader than Guardant's, covering more than 300 cancer-related genes. In addition to single-gene alterations, the test also reports on the presence of multi-gene signatures, namely microsatellite instability and blood tumor mutational burden, which can help guide the use of cancer immunotherapies.

FoundationOne Liquid CDx joins Foundation's FDA-approved tissue sequencing test FoundationOne CDx, which received approval in 2017.

Foundation highlighted in a statement that cancer patients whose liquid biopsy results indicate they are negative for companion diagnostic mutations can be reflexed to FoundationOne CDx to confirm their mutation status.

In its new approval, FDA has included four official companion diagnostic indications for the firm's liquid biopsy test. The test is recognized as a companion to Clovis Oncology's PARP inhibitor rucaparib (Rubraca) in men with metastatic castration-resistant prostate cancer (mCRPC).

The test is also approved for three companion indications in lung cancer: for the EGFR tyrosine kinase inhibitors gefitinib (AstraZeneca's Iressa), osimertinib (AstraZeneca's Tagrisso), and erlotinib (Genentech's Tarceva)

Foundation said it is also seeking additional drug-specific claims to further enhance the clinical utility of it test.

"Liquid biopsies are becoming an increasingly important option to inform personalized treatment decisions for physicians treating certain advanced cancer patients who require minimally invasive solutions to genomic testing," Mark Socinski, a medical oncologist at the AdventHealth Cancer Institute in Orlando, Florida said in a statement.

"This approval helps expand access to important genomic information needed for physicians to make more informed decisions about targeted treatment approaches for their patients and is another important step toward making comprehensive genomic testing a part of routine clinical cancer care," he added.

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