Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, today announced that it has applied the CE mark to the PGDx elio™ tissue complete assay. This milestone advances PGDx’s vision to bring comprehensive genomic profiling to molecular labs globally, and allows PGDx to provide greater access to precision medicine for cancer patients in the European Union (EU).
We’re pleased to bring these comprehensive, regulated genomic panels to the EU and look forward to showcasing the PGDx elio assays at the upcoming European Society for Medical Oncology Congress in Barcelona, Spain. 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. With this assay, physicians throughout Europe will be able to secure specific, actionable information that can help them make improved treatment decisions.”
Doug Ward, Chief Executive Officer at PGDx
The PGDx elio tissue complete panel is a 507-gene test for somatic alterations that detects single nucleotide variants (SNVs), small insertion/deletions (indels), amplifications, rearrangements, microsatellite instability (MSI) and tumor mutation burden (TMB). The use of TMB and MSI for the identification of cancer patients whose tumors may respond to immune checkpoint inhibitor therapy has recently been investigated in clinical trials (TMB) and approved (MSI) by the U.S. Food and Drug Administration (FDA).
CE marking indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). With CE marking of both elio plasma resolve and elio tissue complete, PGDx 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.
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