Memorial Sloan Kettering Cancer Center (MSK) has won the FDA’s first authorization for a first tumor-profiling laboratory-developed test (LDT)—an approval that has led the agency to create a regulatory pathway for reviewing similar assays.
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) is a 468-gene panel intended to detect gene mutations and other critical genetic aberrations in both rare and common cancers. Since 2014, pathologists in the Molecular Diagnostics Service of the cancer center’s Department of Pathology have used MSK-IMPACT to analyze the tumor DNA of essentially all patients with advanced solid cancers, MSK said.
MSK-IMPACT 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 such as point mutations and small insertions and deletions, as well as microsatellite instability (MSI). MSK cautions that the assay 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, MSK said.
“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,” MSK physician-in-chief José Baselga, M.D., Ph.D., said in a statement.
FDA Creates Pathway to Review Tumor Assays Based on Approval of MSK Panel