FDA Authorizes IMPACT Test to Speed Precision Oncology Treatment

The FDA has authorized an in vitro diagnostic test that can rapidly identify cancer mutations and allow oncologists to determine treatment options more quickly, according to a press release from the Agency.

The Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT) diagnostic test was developed by the Memorial Sloan Kettering Cancer Center to identify biomarkers for various forms of cancer, including lung cancer. The test is an in vitro diagnostic test, which the FDA stated was able to identify a higher number of genetic mutations than any other previously reviewed test.

Impact uses next-generation sequencing to quickly determine the presence of mutations in 468 unique genes. The test can also identify other abnormalities in the genetic makeup of a tumor.

“The goal of allowing next-generation sequencing -based tumor profiling tests to undergo review by accredited third-parties is to reduce the burden on test developers and streamline the regulatory assessment of these types of innovative products,” Scott Gottlieb, MD, commissioner of the FDA, said in the press release. “We’ll continue to look for opportunities to create regulatory efficiencies where possible to drive broader access to tools that improve American health, while maintaining the safety and efficacy standards that patients should expect from their FDA-reviewed products.”

The IMPACT test authorization comes as cancer-profiling test begin to gain wider acceptance. The ability to identify which mutations are present will give oncologists the ability to fine tune treatments based on available clinical data, opening the door to more precise medicine.

“Pathology guides almost every decision point in the cancer treatment process, and IMPACT has enabled our pathologists to provide a better understanding of the genetic underpinnings of each patient’s illness,” David Klimstra, MD, Chair of the Department of Pathology and James Ewing Alumni Chair of Pathology at Memorial Sloan Kettering, said in a press release. “The valuable data obtained through the sequencing can guide treatment choices and, in some cases, identify patients who are candidates for a cancer clinical trial.”

—David Costill

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