Personal Genome Diagnostics Gets FDA Breakthrough Device Designation for Liquid Biopsy

Jul 24, 2018

This article has been updated from a previous version to clarify a statement about FDA-approved liquid biopsies.

NEW YORK (GenomeWeb) – Personal Genome Diagnostics said today that its PGDx Elio Plasma Resolve cell-free DNA assay has received a Breakthrough Device Designation from the Food and Drug Administration's Center for Device and Radiological Health.

PGDx's Elio assay uses next-generation sequencing to detect SNVs, amplifications, rearrangements, and microsatellite instability status to guide therapy selection for cancer patients.

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