FDA Approves FoundationOne Liquid CDx for Breast, Ovarian, Lung Cancer Indications

The FDA has approved the FoundationOne Liquid CDx for use as a companion diagnostic for 3 targeted therapies: alpelisib (Piqray) in advanced or metastatic breast cancer, rucaparib (Rubraca) in advanced ovarian cancer, and alectinib (Alecensa) in a specific type of metastatic non—small cell lung cancer (NSCLC).¹ The regulatory agency also gave the green light to a label expansion for the diagnostic to report additional select copy number alterations and genomic rearrangements, according to an announcement from Foundation Medicine, Inc.

“FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients, regardless of the type of cancer they have,” Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine, stated in a press release. “These 3 additional companion diagnostic claims expand the test’s clinical utility into breast and ovarian cancer, demonstrating our commitment to bringing precision medicine to more patients, and we plan to continue working with our biopharma partners to increase that reach.”

FoundationOne Liquid CDx is a companion diagnostic that evaluates guideline-recommended genes from a blood sample; the test is capable of evaluating over 300 genes.² The blood-based biopsy also reports blood tumor mutational burden, microsatellite instability, and tumor fraction values. The goal of the test is to help inform treatment approaches and predict benefit of certain targeted therapies in patients across several cancer indications.

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