The Food and Drug Administration (FDA) has authorized Memorial Sloan Kettering Cancer Center’s (MSKCC) tumor profiling test IMPACT, which stands for integrated mutation profiling of actionable cancer targets. The IMPACT test compares tumor tissue to a sample of normal tissue from the same patient to detect genetic alterations that might help guide treatment options. Using next-generation sequencing, the test rapidly identifies mutations in 468 unique genes—a higher number of oncogenic mutations than any test previously reviewed by FDA—as well as other molecular changes in the genomic makeup of a person’s tumor.
FDA evaluated the test through the de novo premarket review pathway for precision, accuracy, and limit of detection. Results indicated that the assay performs with greater than 99% accuracy and is capable of detecting a mutation at a frequency of approximately 5%. Additionally, when compared to traditional methods, IMPACT’s detection of microsatellite stability was concordant more than 92% of the time across multiple cancer types in 175 cases.