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PGDx Inks Agreements With KingMed, Merck for Tissue-Based TMB Testing

NEW YORK (GenomeWeb) – Personal Genome Diagnostics has entered into a strategic collaboration with China's KingMed Diagnostics to use PGDx's Elio tissue complete assay to detect tumor mutational burden and other gene variants.

Separately, PGDx said it has also partnered with Merck as part of a phase II precision oncology study.  

As part of the collaboration with KingMed, the partners will establish KingMed as a qualified clinical trial testing site for the Elio tissue complete assay, with a focus on TMB and other variants of relevance for immuno-oncology drug development. Once the assay is approved by China's and Hong Kong's regulatory bodies, the firms believe that the partnership will allow local patient access to the screening technology.

According to Baltimore, Maryland-based PGDx, the partnership will provide value for pharmaceutical companies seeking to test patients for tumor mutational burden and other relevant variants for immuno-oncology drug development in China and Hong Kong.

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. The company also market the Elio plasma resolve assay, a qualitative in vitro diagnostic test that detects similar variant types in circulating cell-free DNA isolated from plasma samples.

"PGDx is developing a portfolio of regulated tissue-based and liquid biopsy products that can provide oncologists and patients with information to help inform critical treatment decisions," PGDx CEO Doug Ward said in a statement. "This collaboration embodies the PGDx vision of bringing comprehensive, kitted next-generation sequencing products to laboratories worldwide, creating greater local testing options for cancer patients globally."

Financial details of the agreement were not disclosed.

In addition, PGDx has signed an agreement with Merck, which will use the Elio tissue complete panel to assess TMB during the enrollment portion of its phase II precision oncology KeyImpact study. The test will explore the application of biomarker-based, pembrolizumab-based therapies for patients with advanced non-small-cell lung cancer. According to PGDx, the study will involve patients from more than 70 clinical sites worldwide.

Ward added that with the PGDx Elio portfolio, PGDx aims to "expand patient access to comprehensive, local genomic testing and reduce turnaround time for results that inform critical treatment decisions for patients worldwide."