FDA approval for FoundationOne Liquid CDx,a comprehensive pan-tumor liquid biopsy test-Foundation Medicine/Roche

Foundation Medicine, Inc. announced that the FDA approved FoundationOne Liquid CDx, the Company’s comprehensive pan-tumor liquid biopsy test. FoundationOne Liquid CDx will be commercially available on Friday, August 28 and is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in accordance with the Centers for Medicare and Medicaid Services National Coverage Decision Memo criteria. FoundationOne Liquid CDx is part of Foundation Medicine’s proven portfolio of FDA-approved tests and acts as: 1.a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including an indication for Rubraca (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase inhibitors (TKIs) for the treatment of non-small cell lung cancer; 2. an FDA-approved test to enable accelerated companion diagnostic development for biopharma companies developing precision therapeutics; and 3. a comprehensive genomic profiling test that reports genomic alteration results, including genomic signatures such as blood tumor mutational burden and high microsatellite instability, as well as single gene alterations, including all NTRK fusions, for patients with any solid tumor as an aid in patient care. The FDA’s approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples.