FDA Approves FoundationOne Liquid CDx as Companion Test for Lynparza in mCRPC Patients

FDA Approves FoundationOne Liquid CDx as Companion Test for Lynparza in mCRPC Patients
The U.S. Food and Drug Administration (FDA) has approved FoundationOne Liquid CDx to be used as a companion diagnostic test to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are likely to benefit from treatment with Lynparza (olaparib). Developed by Foundation Medicine, the test is a blood-based biopsy assessment approved by the FDA to analyze the genetic signature of solid tumors, with the goal of identifying patients who may benefit from certain FDA-approved targeted cancer therapies. Capable of detecting alterations in more than 300 cancer-related genes, FoundationOne Liquid CDx is currently the most comprehensive companion diagnostic test for solid tumors available on the market. The U.S. agency has now specifically approved the test to identify men with mCRPC carrying mutations in BRCA and/or ATM DNA repair genes, who are likely to respond to Lynparza. FoundationOne CDx, the company’s tissue-based genomic profile test, was also approved earlier this year to be used as a companion diagnostic test for Lynparza. “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,” Brian Alexander, MD, chief medical officer at Foundation Medicine, said in a press release. “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.” “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,” he added. Joint
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