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Personal Genome Diagnostics (PGDx) and Merck are looking to find the right combination to enhance and improve cancer therapy. Both companies hope to achieve this goal through an IDE FDA recently granted to Baltimore-based PGDx.
The IDE gives PGDx approval for the use of its elio tissue complete assay in a Merck trial of pembrolizumab-base combination therapy. The elio assay will be used during the trial to analyze genomic markets to direct patient enrollment and stratification.
PGDx’s elio tissue complete panel is a 500+ gene test for somatic alterations that detect single nucleotide variants (SNVs), small insertion/deletions, amplifications, rearrangements, microsatellite instability (MSI) and tumor mutation burden.
PGDx provides genomic solutions from biomarker discovery to companion diagnostic development through its CAP/CLIA certified laboratory and is developing a portfolio of regulated tissue-based and liquid biopsy genomic products to enable local next-generation sequencing (NGS) testing in laboratories worldwide.
“We’re pleased with FDA’s decision to approve PGDx’s elio tissue complete assay for this trial, as it validates the robustness of the test and reinforces the role of diagnostic biomarkers in investigating treatment strategies for patients living with cancer,” said Doug Ward, CEO at PGDx. “Further, Merck’s selection of this assay for use in their trials underscores its value and performance in ongoing oncology research.”