Personal Genome Diagnostics CE Marks Liquid Biopsy Test

Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, today announced that it has applied the CE mark to PGDx elio™ plasma resolve. It is the first kitted plasma-based NGS oncology test to have that certification, enabling greater access to genomic testing for cancer patients in Europe.

PGDx elio™ plasma resolve is a qualitative in vitro diagnostic test that uses targeted high throughput, parallel-sequencing technology to detect single nucleotide variants (SNVs), small insertion/deletions (indels), amplifications, rearrangements, and microsatellite instability (MSI) in a broad multi-gene panel in circulating cell-free DNA (cfDNA) isolated from plasma samples. It encompasses several clinically actionable variants across tumor types, enabling more informed treatment decisions.

“We are extremely proud of this important milestone,” said Doug Ward, Chief Executive Officer. “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 PGDx 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.”

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