The U.S. Food and Drug Administration (FDA) approved Memorial Sloan Kettering Cancer Center’s (MSKCC) tumor profiling test as an in vitro diagnostics (IVD). FDA also accredited New York State Department of Health (NYSDOH) as a third-party reviewer of IVDs. MSKCC’s MSK-IMPACT clinical trial used next-generation sequencing (NGS) to detect mutation profiles of 486 genes in tumor tissues. The NGS-based test is capable of detecting the mutation frequency of approximately 5% (range of 2-5%) with an accuracy of more than 99%. The test also includes the microsatellite instability test (MSI). In 175 patients with cancers across multiple cancer types, the concordance of the results using the MSI test and using traditional methods is 92%. MSKCC’s tumor profiling test is approved to be an IVD test where detection of one genetic mutation is not restricted to the use of one single drug. The test is approved to provide comprehensive therapeutic information with higher specificity based on detected mutations.