On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating cell-free DNA (cfDNA) in blood samples collected from cancer patients.
Foundation One® Liquid CDx is intended for use as a companion diagnostic to detect and report substitutions, insertions, and deletions in 311 genes, and will help identify patients who may benefit from certain FDA-approved targeted therapies. For example, the test is approved to identify EGFR mutations in non-small cell lung cancer patients for treatment with IRESSA® (gefitinib), TAGRISSO® (osimertinib), or TARCEVA® (erlotinib). The test is also approved to identify BRCA1 and BRCA2 mutations in prostate cancer patients for treatment with RUBRACA® (rucaparib).
Foundation One® Liquid CDx can benefit patients with advanced cancer. The test offers physicians options for detecting genomic alterations that help guide efficient, personalized cancer treatment decisions. The test can also provide complementary insights to tissue-based testing regarding tumor heterogeneity (the differences among cancer cells), and clonal evolution (how tumors evolve over time).
The Foundation One® Liquid CDx became commercially available on August 28, 2020, and is covered by Medicare and Medicare Advantage for all solid tumors.
This news follows FDA’s first premarket approval of a combination liquid biopsy / NGS test (on August 7, 2020) issued for Guardant Health’s Guardant360TM CDx, which can detect mutations in 55 genes.