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NEW YORK (GenomeWeb) – Natera said this week that the US Food and Drug Administration has granted breakthrough device designation for its circulating tumor DNA test, which is currently available for research. The ctDNA test, Signatera, is a bespoke assay that analyzes a handful of mutations in a patient's tumor identified through tumor biopsy and sequencing. The FDA granted the designation for Signatera for use in patients previously diagnosed with certain cancer types and in combination with certain drugs.

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