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Medical Devices / Submissions and Approvals

FDA Approves MSK’s IMPACT Tumor Profiling Assay

Nov. 17, 2017

The FDA authorized Memorial Sloan Kettering Cancer Center’s IMPACT in vitro diagnostic test for tumor profiling, noting the assay can identify a higher number of genetic mutations in cancers than any test previously reviewed by the agency.

The IMPACT assay uses next-generation sequencing to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the tumor.

The IMPACT test was reviewed through the de novo premarket review pathway.

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