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.

Read FDA press release

Michael Wonder

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Michael Wonder

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Cancer , US , Process , Device , Diagnosis