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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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Jul
23

This webinar will discuss a study that set to assess the efficacy and safety of osimertinib in EGFR T790M positive non-small cell lung cancer (NSCLC) patients identified by using plasma sample and cobas EGFR Mutation test v2. This is the first prospective study to use liquid biopsy upfront to evaluate osimertinib efficacy.