Last week, the Food and Drug Administration approved a diagnostic test created by researchers at Memorial Sloan Kettering Cancer Center that can rapidly identify mutations in 468 unique genes and track changes in the genomic makeup of a cancerous tumor.
The test, known as MSK-IMPACT, provides a new pathway for precision medicine, allowing physicians to tailor treatments based on the sequencing results and help identify patients who are eligible for clinical trials.
The test was approved by the New York State Department of Health in 2014, and has already been used to treat more than 20,000 patients at Memorial Sloan Kettering, according to an announcement. The FDA used the NYSDOH as an accredited third-party reviewer, which meant MKS didn’t have to submit a separate 510(k) application.
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“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,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in an announcement. “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.”
Michael Berger, Ph.D., the associate director of the Marie-Josée and Henry R. Kravis Center for Molecular Oncology at MSK who led the development of the test, said it “will set a precedent for future authorization of tests developed by both academic and commercial labs.”
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But beyond the clinical implications of the newly approved test, Memorial Sloan Kettering said it plans to make all of the data collected through MSK-IMPACT available to the larger scientific community through a database called cBioPortal. The de-identified data will allow researchers to explore the connections between genetic mutations and the therapy that patient received.
The genomic data will also be shared through the American Association for Cancer Research’s Project GENIE, a data-sharing partnership between eight of the nation’s top cancer centers to share genetic sequencing information. Researchers have argued that both collecting and sharing clinical data has become a particularly crucial aspect of precision medicine research.
Berger added that MSK intends to build a database of patients and their mutations to more quickly and effectively enroll patients in clinical trials.