Foundation Medicine Inc. announced on 9 November that the US Food and Drug Administration has approved its FoundationOne Liquid CDx test for use as a companion diagnostic with AstraZeneca PLC and Merck & Co., Inc.’s Lynparza (olaparib)
FDA Approves Foundation Medicine Liquid Biopsy Test As Companion Diagnostic For Lynparza
The US FDA expanded the use of FoundationOne Liquid CDx as a companion diagnostic for certain prostate cancer patients eligible for treatment with olaparib.
More from Approvals
• By
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.
• By
The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.
• By
Tempering expectations on the immediate market impact for the upgraded continuous glucose monitor, Dexcom notes insurance coverage and pump integrations will take time to finalize.
• By
The device, which uses a flexible frame to ease insertion and minimize the dose of copper, is 99% effective in preventing pregnancy. Clinical trial lead David Turok said it represents “a real advance” in contraceptive options.
More from Policy & Regulation
• By
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
• By
Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
• By
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.