FDA approves Foundation's pan-tumor liquid biopsy product for approval.

On August 26, Foundation Medicine announced that the FDA had approved Its Pan-Tumor Liquid Biopsy Product, Foundation One Liquid CDx.
The product is a qualitative in vitro diagnostic (IVD) test based on next-generation sequencing (NGS), which analyzes 324 genes using circulating free DNA (cfDNA) isolated in the outer blood of patients with advanced cancer and reports short variations of 311 genes, including redeployment and copy loss of BRCA1/2.
FoundationOne Liquid CDx can be used for the following purposes: as an accompanying diagnosis, to determine which patients may benefit from fdantal-approved specific targeted therapies, including the screening of patients with metastatic degenerative prostate cancer with BRCA1/2 gene mutations for PARP inhibitor Rubraca, and three first-line patients with tyrosine kinase inhibitors (TKI) for non-small cell lung cancer; Accelerated accompanying diagnostic development for biopharmaceutical companies developing precision therapy drugs, and as a whole genome spectrum analysis (CGP), reporting genomic change results (including blood tumor mutation load TMB and high microsatellite instability MSI, as well as single gene variants, including all types of NTRK fusion), to guide the care of patients with any solid tumor.
FDA-approved FoundationOne Liquid CDx is based on more than 7,500 samples of more than 30 cancer types and 30,000 unique variants of analytical and clinical validation studies.
the liquid biopsy product using multiple validation methods spanning multiple tumor types showed high sensitivity and specificity.
: FDA Approves Foundation Medicine's FoundationOne®Liquid CDx, a Comprehensive Pan-Liquid Tumor Biopsy Test with Multiple Companion Diagnostics For Patients with Advanced Cancer. Retrieved Aug 26,2020,