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

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



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

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 (NGS) to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a person’s tumor. Cancer profile tests are gaining wider acceptance. By identifying what genetic mutations are present in a particular tumor, the test results can provide patients and health care professionals with useful insight that may help inform how best to treat the cancer. Continue reading.