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PGDx, PathGroup to Co-Develop Genomic Profiling Assay

NEW YORK (GenomeWeb) – Personal Genome Diagnostics announced today that it has signed a co-development agreement with PathGroup for the PGDx Elio tissue-based complete assay.

As part of the agreement, the firms will partner on the necessary studies to support and secure US regulatory approval for the Elio tissue complete assay. PathGroup said it plans to be the first US laboratory to use the Elio panel.

PGDx's Elio tissue complete panel uses high-throughput sequencing technology to detect more than 500 gene variants, including TMB, single nucleotide variants, small insertions and deletions, amplifications, rearrangements, and microsatellite instability.

"We believe this partnership will offer physicians and patients new horizons for advanced diagnostic content beyond what is currently available, significantly advance our offering for genomic oncology services and, ultimately improve patient care," PathGroup CEO Ben Davis said in a statement.

According to PGDx, the collaboration integrates the firm's scientific, development, and regulatory expertise with PathGroup's experience incorporating clinical next-generation sequencing into patient care.

"PGDx is developing a portfolio of regulated tissue-based and liquid biopsy products for laboratories worldwide that can provide oncologists and patients with information to better understand the patient's cancer and make critical treatment decisions," PGDx CEO Doug Ward said in a statement.

PGDx previously inked separate agreements with KingMed Diagnostics and Merck last week to use the Elio assay to detect TMB and other gene variants.