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TEST:
NYU Langone Genome PACT assay

Type:
FDA Cleared (510k)

Details

Evidence
NYU Langone Genome PACT (Profiling of Actionable Cancer Targets) is a qualitative in vitro diagnostic test that uses targeted DNA next-generation sequencing tumor tissue matched with normal specimens from patients with malignant neoplasms to detect tumor gene alterations in exons and selected promoter of 607 genes. The genome PACT is intended to provide information on somatic mutations including point mutations and small insertions and deletions for diagnostic and treatment decisions. Detected mutations are matched with available standard of care therapy or clinical trial providing critical information for the best management.
Cancer:
Solid Tumor
Gene:
AKT1 (V-akt murine thymoma viral oncogene homolog 1), APC (APC Regulator Of WNT Signaling Pathway), ATM (ATM serine/threonine kinase), EGFR (Epidermal growth factor receptor), GNA11 (G Protein Subunit Alpha 11), GNAQ (G Protein Subunit Alpha Q)
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Method:
Next-Generation Sequencing (NGS)
Approvals
Date
Cancer
Gene
Drug
By
07/15/21
FDA Cleared (510k)