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FDA Approves FoundationOne Liquid CDx to Select BRCA-Mutated mCRPC Patients for Janssen's Akeega

NEW YORK – Roche subsidiary Foundation Medicine said Monday that the US Food and Drug Administration has approved its liquid biopsy test, FoundationOne Liquid CDx, as a companion diagnostic to identify advanced BRCA-mutated prostate cancer patients who are eligible for treatment with Janssen's Akeega (niraparib and abiraterone acetate). 

Last year, Janssen's PARP inhibitor-hormone therapy combination netted FDA approval in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mRPC). At the time, the FDA approved Foundation Medicine's tissue-based next-generation sequencing test, FoundationOne CDx, as a companion diagnostic to identify patients with BRCA mutations. Now, the FDA has extended the label to include the blood-based test. 

"We know how challenging it can be to obtain a tissue sample for testing in advanced cancers such as mCRPC, making liquid biopsy an incredibly important tool in a provider's toolbox for the development of personalized treatment plans for their patients," Foundation Medicine Chief Medical Officer Mia Levy said in a statement. According to Levy, healthcare providers can reflex to the tissue-based test if they need to do so. 

FoundationOne Liquid CDx is designed to analyze more than 300 cancer-related genes from a patient's blood sample.