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Medical Devices / Submissions and Approvals

Personal Genome’s Tissue Complete Assay Gets CE Marked

Sept. 26, 2019
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Personal Genome Diagnostics has gained the CE Mark for another PGDx elio panel, this time for its tissue complete assay.

The panel tests for somatic alterations across 507 genes. It can detect single nucleotide variants, small insertion/deletions, amplifications and rearrangements.

The tissue complete assay also tests for microsatellite instability (MSI) and tumor mutation burden (TMB). MSI has received FDA approval for identifying cancer patients whose tumors may respond to immune checkpoint inhibitor therapy and the use of  TMB for that purpose is at the clinical trial stage.

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