FDA Action on MSK Tumor Profiling Assay Breaks Ground on Multiple Fronts

FDA on Thursday authorized a faster approval path for a next-generation sequencing (NGS) assay developed at Memorial Sloan Kettering Cancer Center (MSK) that represents both a scientific and regulatory breakthrough at the agency.

The diagnostic test, known as IMPACT, identifies more genetic mutations, or biomarkers, for cancer “than any test previously reviewed by the agency,” according to an FDA statement. What’s more, FDA simultaneously announced that it was granting accreditation to the New York State Department of Health (NYSDOH) to act on its behalf, and that tests that passed muster with that agency would not need a separate FDA clearance.

IMPACT, which stands for Integrated Mutation Profiling of Actionable Cancer Targets, allows clinicians to look beyond the mutations in solid tumor cancers—lung, colon, breast, and melanoma—to aid patients with less common solid tumors. Because NGS casts a wider net than conventional genetic testing, it allows researchers in phase I “basket studies” to find out quickly if cancer therapies can be used in rarer cancers beyond those for which they are already approved.

The test had been submitted through FDA’s de novo premarket review pathway, reserved for low- to moderate-risk devices. It had previously been cleared by NY state health regulators, who had cleared it for use. Thursday’s action created a Class II pathway for these types of tests, allowing them to be cleared either through FDA or by an accredited third party.

Third-party accreditation allows FDA to keep up with the pace of innovation and encourage test developers to voluntary seek 510(k) clearance, said FDA Commissioner Scott Gottlieb, MD.

“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,” he said. “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.”

“NGS 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,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in the statement.

“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 MSK to help ensure that the IMPACT test is accurate, reliable and clinically meaningful. 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.”