Pan-Tumor Liquid Biopsy Test Approved by FDA as Companion Diagnostic for Rucaparib
Posted: Tuesday, September 1, 2020
On August 27, the U.S. Food and Drug Administration (FDA) approved FoundationOne®Liquid CDx, a comprehensive pan-tumor liquid biopsy test, as a companion diagnostic for the PARP inhibitor rucaparib. It will be used to identify patients with BRCA1/2-mutant metastatic castration-resistant prostate cancer who may benefit from treatment with specific FDA-approved targeted therapies. In addition, the companion diagnostic was simultaneously approved for three tyrosine kinase inhibitors for first-line treatment of non–small cell lung cancer.
The liquid biopsy test is designed as a qualitative next-generation sequencing–based in vitro diagnostic test. Using a blood sample, it analyzes more than 300 cancer-related genes for alterations. The test results are delivered in an integrated report, which identifies alterations matched to FDA-approved therapies and delivers information about the genomic signatures 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 approval was based on analytic 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 low allele frequencies.