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.