The FDA is taking a three-tiered approach to next-generation sequencing oncology with a newly approved tumor profiling assay, the accreditation of the New York Department of Health as an FDA third-party reviewer, and the creation of the Class II regulatory pathway for these devices.
Memorial Sloan Kettering Cancer Center’s qualitative in vitro diagnostic test — the Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT) — was designed for identifying a larger number of genetic mutations, otherwise known as biomarkers, than any other test that the FDA has previously reviewed.
The insight gathered from IMPACT’s detection of mutations in 468 unique genes will be used to guide treatment decisions as part of care plans for cancer patients.
Laboratories’ NGS-based tests that have been approved by the NYSDOH will not require a separate 510(k) submission to the FDA. Other FDA third-party reviewers could also become eligible to make clearance recommendations to the agency for tests that are similar to IMPACT.
“The goal of allowing NGS-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 said. “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.” — Ana Mulero