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FDA Clears FoundationOne Liquid CDx for Identifying BRCA-Mutated mCRPC Patients Eligible for Janssen's Akeega

NextEdge Admin

01 Jul 2024

2 min 36 sec

Foundation Medicine, a subsidiary of Roche, announced that the US Food and Drug Administration (FDA) has granted approval to its liquid biopsy test, FoundationOne Liquid CDx, as a companion diagnostic. This approval allows it to identify advanced prostate cancer patients with BRCA mutations who may benefit from treatment with Janssen's Akeega (niraparib and abiraterone acetate).

Previously, Janssen's combination of a PARP inhibitor and hormone therapy received FDA approval for adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mRPC). Initially, Foundation Medicine's tissue-based next-generation sequencing test, FoundationOne CDx, was approved as a companion diagnostic for identifying patients with BRCA mutations. The recent FDA decision extends this label to include the blood-based FoundationOne Liquid CDx test.

Dr. Mia Levy, Chief Medical Officer at Foundation Medicine, emphasized the significance of liquid biopsy in advanced cancer diagnostics, particularly in cases where obtaining tissue samples is challenging. She highlighted that healthcare providers can seamlessly use the liquid biopsy test to develop personalized treatment plans. If needed, providers can also reflex to the tissue-based test for comprehensive genomic profiling.

FoundationOne Liquid CDx is specifically designed to analyze over 300 cancer-related genes using a patient's blood sample. This broader genomic profiling capability enables clinicians to identify various genetic alterations that could influence treatment decisions, thereby enhancing the precision and efficacy of personalized cancer therapies.

The FDA's approval of FoundationOne Liquid CDx marks a significant advancement in the field of precision medicine, offering oncologists a non-invasive yet comprehensive tool to guide treatment strategies based on the genetic profile of individual patients with advanced prostate cancer and BRCA mutations.