FDA Approves FoundationOne Liquid CDx as Companion Diagnostic for Olaparib in Prostate Cancer

The FDA has approved the FoundationOne Liquid CDx for use as a companion diagnostic with olaparib (Lynparza), which is indicated for select patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene—mutated metastatic castration-resistant prostate cancer (mCRPC).^1,2 The diagnostic will utilize a blood-based biopsy to identify patients with mCRPC who harbor BRCA1, BRCA2, and/or ATM alterations who may be appropriate candidates for treatment with the PARP inhibitor.

“With this latest companion diagnostic approval, physicians now have the option to choose either tissue or liquid-based comprehensive genomic testing based on their patients’ need and condition. Since tissue availability can be an issue for some [patients with] metastatic prostate cancer, blood-based testing is an important option to consider and critically important for informing patient care,” Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine, stated in a press release.

Previously, in August 2020, the FoundationOne Liquid CDx was approved by the FDA for all solid tumors with multiple diagnostic indications.^3,4 The decision was based on analytical and clinical validation trials that collected more than 7500 samples and 30,000 unique variants across over 30 tumor types. When the platform was evaluated across these various tumors, the test demonstrated high sensitivity and specificity, even at the low allele frequencies that were observed in the blood samples that had been collected.

Click to continue reading on OncLive.