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BioWorld - Tuesday, June 23, 2026
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Home » FDA grants breakthrough designation to Foundation for liquid biopsy assay
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FDA grants breakthrough designation to Foundation for liquid biopsy assay

April 27, 2018
By Liz Hollis
A liquid biopsy assay that incorporates multiple companion diagnostics has gotten a boost from the FDA. Cambridge, Mass.-based Foundation Medicine Inc. reported that the agency had granted a breakthrough device designation for an expanded version of its FoundationACT (Assay for Circulating Tumor DNA) assay, which would include more than 70 genes and genomic biomarkers for microsatellite instability and blood tumor mutational burden.
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