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FDA Approves FoundationOne Liquid CDx, a Pan-Tumor Liquid Biopsy Test


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On August 28, the U.S. Food and Drug Administration (FDA) approved FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test for patients with solid tumors. FoundationOne Liquid CDx is a comprehensive genomic-profiling test that analyzes more than 300 cancer-related genes and multiple genomic signatures. These insights can help physicians to determine a personalized treatment plan for individual patients based on the specific mutations identified.

As well as approving FoundationOne Liquid CDx as a comprehensive genomic profiling test for patients with any solid tumor, the FDA approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer therapies, including rucaparib, a PARP inhibitor for treatment in patients with BRCA1/2–mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase inhibitors for the treatment of patients with non–small cell lung cancer. By incorporating multiple genes, including several companion diagnostic biomarkers, the test can help save time vs sequential biomarker testing.

FoundationOne Liquid CDx analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in the BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. The report also delivers information about genomic signatures—including microsatellite instability and tumor mutational burden—as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies, and provides relevant clinical trial information.

The FDA approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies including more than 7,500 samples and 30,000 unique variants across more than 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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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