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TEST:
PGDx elio™ tissue complete assay

Company:
LabCorp
Type:
FDA Approved
Related tests:

Details

Evidence
PGDx elio™ tissue complete is a comprehensive, in-vitro diagnostic, next generation sequencing (NGS) assay that identifies key genomic alterations and guideline supported biomarkers in solid tumors using a 500+ gene panel. PGDx elio™ tissue complete is the industry’s first and only NGS diagnostic kit for comprehensive tumor profiling that is FDA-cleared for use in labs across the country. This assay identifies somatic mutations with high accuracy and sensitivity, providing information on single nucleotide variants, insertions/deletions (indels), amplifications, translocations, microsatellite instability (MSI) status and tumor mutation burden (TMB) to qualified healthcare professionals for use in accordance with NCCN guidelines.
Cancer:
Solid Tumor
Gene:
ALK (Anaplastic lymphoma kinase), BRAF (B-raf proto-oncogene), GATA6 (GATA Binding Protein 6), HER-2 (Human epidermal growth factor receptor 2), HRAS (Harvey rat sarcoma viral oncogene homolog), MSI (Microsatellite instability)
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Method:
Next-Generation Sequencing (NGS)
Approvals
Date
Cancer
Gene
Drug
By
04/24/20
FDA