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.
On Aug. 7 the FDA approved Guardant360 CDx for profiling multiple tumor mutations, also known as comprehensive genomic profiling, in patients with any solid tumor.
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