PGDx elio™ tissue complete (ETC)

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The PGDx elio™ tissue complete (ETC) assay is an FDA cleared NGS assay that uses tumor tissue from patients to detect tumor gene alterations. ETC is a 505 gene panel and is intended to provide tumor molecular profiling information on somatic alterations (SNVs, small insertions and deletions, 1 amplification and 4 translocations), microsatellite instability (MSI) and tumor mutation burden (TMB).

The PGDx elio™ tissue complete assay (ETC) is an FDA cleared qualitative in vitro diagnostic device that uses targeted next generation sequencing (NGS) of DNA isolated from FFPE tumor tissue from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi-gene panel.  PGDx elio tissue complete is a 505 gene panel and is intended to provide tumor molecular profiling information on somatic alterations (SNVs, small insertions and deletions, one amplification and four translocations), microsatellite instability (MSI) and tumor mutation burden (TMB) for use by qualified healthcare professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients. The assay takes less than 5 days from DNA to report and includes automated machine-learning software to generate reports.