NEW YORK (GenomeWeb) – Personal Genome Diagnostics said today that its PGDx Elio Plasma Resolve liquid biopsy assay has received CE marking.
The in vitro diagnostic uses next-generation sequencing to detect single-nucleotide variants, small insertions and deletions, amplifications, rearrangements, and microsatellite instability in circulating cell-free DNA isolated from plasma samples to guide therapy selection for cancer patients. PGDx also markets a tissue-based version of the test.
"The CE mark of PGDx Elio Plasma Resolve allows us to bring this product to Europe, providing greater access to patients who could benefit from genomic testing, particularly those who cannot provide tissue samples," PGDx CEO Doug Ward said in a statement.
In mid-2018, the PGDx Elio Plasma Resolve received a Breakthrough Device Designation from the Food and Drug Administration's Center for Device and Radiological Health. And, in October, Baltimore, Maryland-based PGDx said that Bristol-Myers Squibb had adopted the test for use in a clinical trial evaluating two of its cancer drugs in patients with certain genetic mutations.