STAT Plus: Foundation Medicine wins FDA approval for first liquid biopsy able to detect multiple cancers
The Food and Drug Administration on Wednesday approved the first comprehensive “liquid biopsy” platform that can detect multiple kinds of cancer from pieces of tumor DNA circulating in a patient’s blood. The Foundation Medicine test is designed to both diagnose disease and match patients’ mutations to genetically targeted therapies.
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. But Foundation Medicine, a Cambridge, Mass., unit of Swiss biopharma Roche (RHBBY), has won the agency’s first nod for a pan-cancer blood assay, which combines liquid biopsy with other kinds of testing to find more diagnostic and genomic biomarkers.
