FDA approves MSK mutation profiling cancer targets

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MSK-IMPACT™ Is the First Tumor-Profiling Multiplex Panel Authorized by the FDA, Setting a New Pathway to Market for Future Oncopanels
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New York, NY,
Wednesday, November 15, 2017

The US Food and Drug Administration (FDA) announced today the authorization of MSK-IMPACT™ (which stands for integrated mutation profiling of actionable cancer targets), a high throughput, targeted-DNA-sequencing panel for somatic mutations. Created by the Department of Pathology at Memorial Sloan Kettering Cancer Center (MSK), MSK-IMPACT is a 468-gene oncopanel intended to detect gene mutations and other critical genetic aberrations in both rare and common cancers. While MSK-IMPACT had previously been approved by the New York State Department of Health as a clinical test, it is now the first tumor-profiling laboratory-developed test (LDT) to receive authorization through the FDA. This decision will help create a new pathway to market for these types of tests.

“This authorization builds on MSK’s rich history of innovation and longstanding commitment to precision medicine and large-scale clinical sequencing,” said José Baselga, MD, PhD, Physician-in-Chief at MSK. “This milestone authorization is a testament to MSK’s expertise in the rapidly expanding field of genome-driven oncology and will set the precedent for future approvals of this type.”

The MSK-IMPACT assay is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing of formalin-fixed, paraffin-embedded tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multigene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and microsatellite instability (MSI) for use by qualified healthcare professionals in accordance with professional guidelines. It is not conclusive or prescriptive for labeled use of any specific therapeutic product. MSK-IMPACT is a single-site assay performed in the diagnostic molecular pathology laboratories at MSK. To date, more than 20,000 MSK patients with advanced cancers have had their tumors sequenced through MSK-IMPACT, and the resulting data have helped guide therapy while providing a wealth of new information about the genomic features of both common and rare cancer types.

The FDA reviewed data for MSK-IMPACT through the de novo premarket review pathway, a regulatory pathway for novel, low- to moderate-risk devices that are not substantially equivalent to an already legally marketed device. Following the de novo authorization, the FDA intends to allow future, similar tests to come to the U.S. market as substantial equivalents.

“The authorization of the MSK-IMPACT assay by the FDA represents the culmination of a considerable joint effort by the MSK team and our counterparts at the FDA. We are grateful for the guidance and helpful dialogue provided by the FDA that made this happen,” said Marc Ladanyi, MD, Attending Pathologist and Chief of the Molecular Diagnostics Service at MSK.

“Pathology guides almost every decision point in the cancer treatment process, and MSK-IMPACT has enabled our pathologists to provide a better understanding of the genetic underpinnings of each patient’s illness,” explained David Klimstra, MD, Chair of the Department of Pathology and James Ewing Alumni Chair of Pathology at MSK. “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.”

“While clinical trials are vital to developing and improving treatments, only 4 percent of all patients enroll in cancer clinical trials each year. MSK-IMPACT is designed to address this problem,” said MSK-IMPACT test developer Michael Berger, PhD, Associate Director of the Marie-Josée and Henry R. Kravis Center for Molecular Oncology and Assistant Attending Molecular Geneticist in the Department of Pathology at MSK. “MSK-IMPACT has helped doctors accelerate the enrollment of patients into cancer clinical trials, potentially leading to earlier approval of new therapies.”