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Personal Genome Diagnostics Gets FDA Breakthrough Device Designation for Liquid Biopsy

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.

Under the Breakthrough Device program, the FDA works with a test developer to reduce the time and cost from development to approval.

"We are excited about what Breakthrough Device Designation for PGDx Elio Plasma Resolve will mean for people with cancer," PGDx CEO Doug Ward said in a statement, noting that it would be "an important advancement for patients who cannot give tissue samples."

Currently, no comprehensive sequencing-based liquid biopsy assay has FDA approval, although Foundation Medicine said it received Breakthrough Device Designation for its FoundationAct test in April, and Guardant Health said in February that the FDA had granted its Guardant360 liquid biopsy assay Expedited Access Pathway designation, where the FDA also works with the developer to reduce time and cost from development to approval.