The OncoMate MSI Dx analysis system from Promega, Madison, Wis, has received the CE mark as a new in vitro diagnostic medical device in Europe. OncoMate MSI is a polymerase chain reaction (PCR)-based validated gold standard for determining microsatellite instability (MSI) status in solid tumors.
“European guidelines recommend MSI testing to assess deficient mismatch repair function of solid tumors for a spectrum of cancers, including colorectal cancer and endometrial cancer, in order to reduce morbidity and mortality,” says Richard Hamelin, PhD, a former research director at the Institut National de la Santé et de la Recherche Médicale (INSERM). “Data show that OncoMate MSI provides clinicians a valuable DNA-based MSI reading that is complementary to a standard mismatch repair immunohistochemistry panel, and can be used as an independent biomarker to predict response to immunooncology therapies.”
Loss of mismatch repair protein function results in tumor cells with DNA MSI. MSI testing is an important first step in the molecular characterization related to loss of mismatch repair function, including Lynch syndrome-related cancers. A study led by Hamelin shows accumulating evidence suggesting that MSI-high status identifies a subset of colorectal cancers with distinctive biological and clinical properties, emphasizing the importance of simple, accurate markers for detection.1 Using a pentaplex PCR system allows for accurate evaluation of tumor MSI status of DNA with high sensitivity and specificity.
OncoMate MSI uses the most sensitive panel of markers for MSI status detection, as included in the European Society for Medical Oncology guidelines. Screening cancer patients with these reliable markers can provide pathologists, oncologists, and patients with information that characterizes tumors to help guide care and treatment decisions.
“Promega MSI technology demonstrates our commitment to developing precise and reliable tools for life scientists around the world,” says Heather Tomlinson, director of clinical diagnostics at Promega. “With the CE marking of OncoMate MSI, Promega aims to make MSI testing more broadly accessible to laboratories within Europe and to aid clinicians in making vital decisions in cancer patient care and treatment.”
For more information, visit Promega.
1. Suraweera N, Duval A, Reperant M, et al. Evaluation of tumor microsatellite instability using five quasimonomorphic mononucleotide repeats and pentaplex PCR. Gastroenterology. 2002;123(6):1804–1811; doi: 10.1053/gast.2002.37070.