FDA approves pan-tumor liquid biopsy test

Aug. 28, 2020

Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne Liquid CDx, a pan-tumor liquid biopsy test, according to a company press release.

Using a blood sample, FoundationOne Liquid CDx, which will be commercially available August 28, analyzes over 300 cancer-related genes for alterations.

FoundationOne Liquid CDx is indicated for use as a companion diagnostic for four FDA-approved precision therapies, including an indication for Rubraca (rucaparib), a PARP inhibitor approved by the FDA for treatment of metastatic castration-resistant prostate cancer patients with BRCA1/2 mutations, and three first-line EGFR-TKIs for the treatment of non-small cell lung cancer patients.

FoundationOne Liquid CDx results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. The report also delivers information about the genomic signature’s microsatellite instability and blood tumor mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies.

The report also provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

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.

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