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FDA Approves Foundation Medicine Liquid Biopsy Test As Companion Diagnostic For Lynparza

 
• By Marion Webb

The US FDA expanded the use of FoundationOne Liquid CDx as a companion diagnostic for certain prostate cancer patients eligible for treatment with olaparib.

Lab technician assistant analyzing a blood sample in test tube at laboratory

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)

Cambridge, MA-based Foundation Medicine, a Roche Holding AG subsidiary, said it will use a blood-based biopsy to detect BRCA1, BRCA2, or ATM genomic alterations in men with metastatic castration-resistant...

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More from Policy & Regulation

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Pathogen Sharing System Part Of Global Pandemic Agreement

 
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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
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The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.