Posted by Michael Wonder on 15 Nov 2017
FDA unveils a streamlined path for the authorisation of tumour profiling tests alongside its latest product action
15 November 2017 - The U.S. FDA today authorised Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumoor 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 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 tumour. Cancer profile tests are gaining wider acceptance.
By identifying what genetic mutations are present in a particular tumour, the test results can provide patients and health care professionals with useful insight that may help inform how best to treat the cancer.
