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FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Three Targeted Therapies

NEW YORK – Foundation Medicine said on Tuesday that the US Food and Drug Administration has approved its FoundationOne Liquid CDx test as a companion diagnostic for three new targeted cancer therapies. 

The test was approved to help identify patients who may benefit from alpelisib (Novartis' Piqray) in advanced or metastatic breast cancer, rucaparib (Clovis Oncology's Rubraca) in advanced ovarian cancer, and alectinib (Genentech's Alecensa) in a certain kind of metastatic non-small cell lung cancer.

Alpelisib is a kinase inhibitor for use in combination with fulvestrant for the treatment of postmenopausal women, as well as men, with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer. Rucaparib is a PARP inhibitor for the treatment of patients with ovarian, fallopian tube, or primary peritoneal cancer who have a deleterious germline or somatic BRCA mutation. Alectinib is a tyrosine kinase inhibitor for the treatment of patients with anaplastic lymphoma kinase-positive metastatic NSCLC.

The FDA also approved a label expansion for the next-generation sequencing test to report additional copy number alterations and genomic rearrangements.

The Roche subsidiary's liquid biopsy test analyzes 324 cancer-related genes in circulating cell-free DNA for genomic alterations and delivers a report identifying alterations matched to specific FDA-approved therapies, the company said. The report also delivers information about microsatellite instability, tumor mutational burden, and single-gene alterations like NTRK fusions.

In August, FoundationOne Liquid CDx was approved for tumor mutation profiling in patients with any solid tumor and as a companion diagnostic for four cancer therapies: rucaparib in men with metastatic castration-resistant prostate cancer and three EGFR tyrosine kinase inhibitors for lung cancer.