On December 4, 2019 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for the use of the company’s elio tissue complete assay in a Merck trial of pembrolizumab-based combination therapy (Press release, Personal Genome Diagnostics, DEC 4, 2019, View Source [SID1234551931]). The PGDx elio assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re pleased with the 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, Chief Executive Officer at PGDx. "Further, Merck’s selection of this assay for use in their trials underscores its value and performance in ongoing oncology research."

The PGDx elio tissue complete panel is a 500+ gene test for somatic alterations that detects 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.