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FDA authorizes IMPACT test to rapidly identify cancer mutations
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The FDA today authorized Integrated Mutation Profiling of Actionable Cancer Targets, or IMPACT, an in vitro diagnostic test that uses next-generation sequencing to rapidly identify the presence of mutations in 468 genes.
The test — developed by Memorial Sloan Kettering Cancer Center — also identifies molecular changes in the genomic makeup of a patient’s tumor. These findings can help inform clinicians about how best to treat the cancer.
The test compares tumor tissue to normal tissue or cells to detect genetic alterations and provide information on cancer biomarkers; however, the FDA noted the test’s results are not conclusive for choosing a corresponding treatment.
The FDA reviewed the IMPACT test through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices that do not have a predicate device. An analysis of the device’s analytical performance, accuracy and limit of detection showed the assay is more than 99% accurate and detects mutations at 5% frequency (range, 2-5). Further, detection of microsatellite instability appeared concordant for 92% of 175 cases across multiple cancer types compared with traditional methods of detection.
“Next-generation sequencing technologies can examine hundreds, if not millions, of DNA variants at a time, and we are only at the beginning of realizing the true potential for these devices to assist patients and their health care providers in learning about the genetic underpinnings of their disease,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release.
Today’s FDA action also advanced a policy framework to efficiently review and make available other next-generation sequencing-based cancer profiling tools.
The agency accredited the New York State Department of Health (NYSDOH) as an FDA third-party reviewer of in vitro diagnostic tests. A laboratory with next-generation sequencing-based profiling tests approved by NYSDOH does not need to submit a separate 510(k) application to the FDA, but can instead request that their NYSDOH application and their state’s review memorandum and application be forwarded to the FDA for 510(k) clearance.
Other third-party reviewers may become eligible for such reviews following FDA accreditation.
“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “As this field advances, we are modernizing the FDA’s approach to the efficient authorization of laboratory tests from developers that voluntarily seek 510(k) clearance. This is another example of where the FDA is working to find creative and flexible approaches to regulation that spurs development and efficient delivery of innovative technology. 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.”
NYSDOH previously conducted its own review of IMPACT and approved it for use among patients in New York. Memorial Sloan Kettering submitted a de novo application to the FDA for the IMPACT test with information submitted for NYSDOH’s prior review, which expedited the FDA’s authorization.
“Recognizing the significant effect information about an individual’s biomarkers can have on their care planning and outcomes, the FDA worked closely with NYSDOH and Memorial Sloan Kettering to help ensure that the IMPACT test is accurate, reliable and clinically meaningful,” Shuren said. “This collaboration is an excellent example of how the FDA can partner with the medical and development communities to review innovative tests as quickly as possible.”