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FDA Approved
Related tests:
MSK-IMPACT is a 468-gene oncopanel intended to detect gene mutations and other critical genetic aberrations in both rare and common cancers. The MSK-IMPACT assay is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing of formalin-fixed, paraffin-embedded tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multigene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and microsatellite instability (MSI) for use by qualified healthcare professionals in accordance with professional guidelines. It is not conclusive or prescriptive for labeled use of any specific therapeutic product. MSK-IMPACT is a single-site assay performed in the diagnostic molecular pathology laboratories at MSK.
Bladder Cancer, Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Endometrial Cancer, Esophageal Cancer, Head and Neck Cancer, Hepatocellular Cancer, Lung Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
ALK (Anaplastic lymphoma kinase), BRAF (B-raf proto-oncogene), EGFR (Epidermal growth factor receptor), FGFR2 (Fibroblast growth factor receptor 2), FGFR3 (Fibroblast growth factor receptor 3), GNA11 (G Protein Subunit Alpha 11)
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Next-Generation Sequencing (NGS)
Confirmatory trial(s)