The Food and Drug Administration on Wednesday approved a comprehensive “liquid biopsy” platform that can detect multiple kinds of cancer and genomic alterations from pieces of tumor DNA circulating in a patient’s blood. The Foundation Medicine test, designed to identify specific types of cancer and match patients’ mutations to genetically targeted therapies, joins one approved earlier this month developed by Guardant Health.
The FDA has previously approved liquid biopsy tests for individual cancers and as so-called companion diagnostics, which identify whether patients are likely to benefit from a specific targeted drug. Foundation Medicine, a Cambridge, Mass., unit of Swiss biopharma Roche (RHBBY), has won the agency’s second nod for a pan-cancer blood assay, which combines liquid biopsy with other kinds of testing to find more diagnostic and genomic biomarkers.
Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!
GET STARTED
What is it?
STAT Plus is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis.
Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.
What’s included?
- Daily reporting and analysis
- The most comprehensive industry coverage from a powerhouse team of reporters
- Subscriber-only newsletters
- Daily newsletters to brief you on the most important industry news of the day
- STAT+ Conversations
- Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
- Exclusive industry events
- Premium access to subscriber-only networking events around the country
- The best reporters in the industry
- The most trusted and well-connected newsroom in the health care industry
- And much more
- Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
