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NEW YORK – Personal Genome Diagnostics said today that it has received an Investigational Device Exemption (IDE) approval from the US Food and Drug Administration for the use of its elio tissue complete assay in a Merck trial of pembrolizumab-based combination therapy. 

Elio tissue complete, a 507-gene NGS test that detects all classes of gene alterations and also reads out measures of microsatellite instability and tumor mutation burden, is being used in the trial to direct patient enrollment and stratification.

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