The Elio tissue complete assay from Personal Genome Diagnostics (PGDx), Baltimore, has received the CE mark, permitting the company to offer its genomic profiling capabilities to molecular labs serving cancer patients in the European Union.

Doug Ward, Personal Genome Diagnostics.

Doug Ward, Personal Genome Diagnostics.

“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,” says Doug Ward, CEO of PGDx. “With this assay, physicians throughout Europe will be able to secure specific, actionable information that can help them make improved treatment decisions.”

The Elio tissue complete panel is a 507-gene test for somatic alterations. It detects amplifications, microsatellite instability (MSI), rearrangements, single nucleotide variants, small insertions/deletions (indels), and tumor mutation burden (TMB). The company’s MSI and TMB test capabilities have recently been investigated in clinical trials for cancer patients with tumors that may respond to immune checkpoint inhibitor therapy, and MSI has received FDA approval.

PGDx was established by researchers in cancer genome sequencing and liquid biopsy technologies from Johns Hopkins University. Having received CE marks for both its Elio plasma resolve and Elio tissue assays, the company plans to further develop its clinical offerings with regulated comprehensive next-generation sequencing panels that enable faster delivery of clinical insights to physicians.

For more information, visit Personal Genome Diagnostics.