FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action

November 15, 2017 – The U.S. Food and Drug Administration today authorized Memorial Sloan Kettering Cancer Center’s (MSK) IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test (assay), an in vitro diagnostic test that can identify a higher number of genetic mutations (biomarkers) that may be found in various cancers than any test previously reviewed by the agency. The IMPACT test uses next-generation sequencing … (leggi tutto)