Personal Genome Diagnostics Inc, Baltimore, has applied the CE mark to its Elio Plasma Resolve next-generation sequencing (NGS) test for oncology.
The test is the first kitted plasma-based NGS oncology test to receive the mark, providing access to the test for cancer patients in Europe. With the CE mark, Personal Genome Diagnostics aims to advance strategic partnerships with molecular laboratory and oncology leaders in the European market to enable genomic testing closer to where patients are treated, expanding the potential of precision medicine.
Elio Plasma Resolve is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel-sequencing technology to detect single nucleotide variants, small insertions and deletions, amplifications, rearrangements, and microsatellite instability in a broad multigene panel, using circulating cell-free DNA (cfDNA) isolated from plasma samples. The test detects several clinically actionable variants across tumor types, enabling more informed treatment decisions.
“We are extremely proud of this important milestone,” notes Doug Ward, CEO of Personal Genome Diagnostics. “Our vision is to improve clinical insight, speed of results, and health economics by delivering a portfolio of regulated tissue-based and liquid biopsy genomic products to laboratories worldwide. The CE mark of 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.”
The Elio Plasma Resolve previously received a breakthrough device designation from FDA’s Center for Devices and Radiological Health in July 2018.
For further information, visit Personal Genome Diagnostics.
Photo: Doug Ward, courtesy of Personal Genome Diagnostics.