Personal Genome Diagnostics (PGDx) said it has applied the CE mark to its PGDx elio tissue complete assay, a distinction the company said will enable it to provide greater access to precision medicine for cancer patients across the European Union.
The PGDx elio tissue complete panel is a 507-gene test for somatic alterations that is designed to detect single nucleotide variants (SNVs), small insertion/deletions (indels), amplifications, rearrangements, microsatellite instability (MSI) and tumor mutation burden (TMB).
CE marking indicates compliance with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). In March, PGDx applied the CE mark to its elio plasma resolve liquid biopsy test, which like elio tissue complete is intended to detect SNVs, indels, amplifications, rearrangements, and MSI, but uses targeted high throughput, parallel-sequencing technology in a broad multi-gene panel in circulating cell-free DNA (cfDNA) isolated from plasma sample.
With CE marking of both elio tissue and its elio plasma resolve, PGDx said, the company aims to provide a new standard of care for cancer patients, with regulated comprehensive next-generation sequencing (NGS) panels that enable faster delivery of clinical insights to physicians.
“The application of the CE mark to the PGDx elio tissue complete assay is an important step forward in expanding patient access to tools that can help personalized cancer care,” PGDx CEO Doug Ward said in a statement. “With this assay, physicians throughout Europe will be able to secure specific, actionable information that can help them make improved treatment decisions.”
Ward added that PGDx looked forward to showcasing the PGDx elio assays at the upcoming European Society for Medical Oncology Congress, to be held September 27 to October 1 in Barcelona, Spain.