NEW YORK – Personal Genome Diagnostics said today that it has successfully CE marked its PGDx Elio tissue complete assay, allowing the company to provide greater access to precision medicine for cancer patients in the European Union.
The 507-gene, next-generation sequencing panel detects single-nucleotide variants, small insertions and deletions, amplifications, rearrangements, microsatellite instability, and tumor mutational burden in DNA patient tissue samples. The assay is intended to help oncologists guide therapy selection for cancer patients across the spectrum of tumor types.
"With this assay, physicians throughout Europe will be able to secure specific, actionable information that can help them make improved treatment decisions," PGDx CEO Doug Ward said in a statement.
The newly CE-marked tissue assay joins PGDx's liquid biopsy test, called Elio Plasma Resolve, which garnered its own CE mark in March.