FDA Creates Pathway to Review Tumor Assays Based on Approval of MSK Panel

Memorial Sloan Kettering Cancer Center (MSK) has won the FDA’s first authorization for a first tumor-profiling laboratory-developed test (LDT)—an approval that has led the agency to create a regulatory pathway for reviewing similar assays. MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) is a 468-gene panel intended to detect gene mutations and other critical genetic aberrations in both rare and common cancers. Since 2014, pathologists in the Molecular Diagnost