FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Lynparza

NEW YORK – Foundation Medicine announced Monday its FoundationOne Liquid CDx test was approved by the US Food and Drug Administration for use as a companion diagnostic with olaparib (AstraZeneca and Merck's Lynparza). 

The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer (mCRPC) that may benefit from treatment with olaparib, Foundation Medicine, a Roche subsidiary, said in a statement. The test also provides a report that shares information about the genomic signatures' microsatellite instability and blood tumor mutational burden, along with single gene alterations.

FoundationOne Liquid CDx, which analyzes 324 cancer-related genes, received approval from the FDA earlier this year to report genomic alteration results for patients with any solid tumor. It is approved as a companion diagnostic for seven targeted therapies across four tumor types, including alpelisib (Novartis' Piqray) for breast cancer and multiple EGFR tyrosine kinase inhibitors for lung cancer. It is also approved for rucaparib (Clovis Oncology's Rubraca) in men with mCRPC and women with advanced ovarian cancer, and for alectinib (Genentech's Alecensa) in a specific metastatic non-small cell lung cancer.  

Foundation's tissue-based comprehensive genomic profiling test, FoundationOne CDx, received approval as a companion diagnostic for olaparib in May.

"Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care," Brian Alexander, chief medical officer at Foundation Medicine, said in a statement. "The approval of this companion diagnostic will allow more patients to access genomic testing, regardless of specimen type, and provide oncologists with another tool to guide personalized treatment decisions."