Promega announces CE marking for OncoMate MSI Dx Analysis System in Europe

Promega Corporation today announced CE marking for the OncoMate™ MSI Dx Analysis System (OncoMate™ MSI) as a new in vitro diagnostic (IVD) medical device in Europe. OncoMate™ MSI is a PCR-based, validated gold standard for determining microsatellite instability (MSI) status in solid tumors. It offers analytical sensitivity and unsurpassed specificity with a short turn-around time.

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. Data show that OncoMate™ MSI provides clinicians a valuable DNA-based MSI reading that is complementary to a standard MMR immunohistochemistry panel and can be used as an independent biomarker to predict response with immuno- oncology therapies.”

Richard Hamelin, Ph.D., Research Director (Ret) at Inserm

Loss of mismatch repair (MMR) protein function results in tumor cells with DNA MSI.6 MSI testing is an important first step in the molecular characterization related to loss of MMR function, including Lynch Syndrome-related cancers.7,8 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.9 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 (ESMO) 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. 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.”

Heather Tomlinson, Director of Clinical Diagnostics at Promega Corporation

Promega MSI technology is one of the leading standard tests for MSI status detection in research laboratories and achieved innovation status and priority review by the National Medical Products Administration (NMPA) in China. It has been used extensively in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications. Promega continues to advance the promise of MSI technology globally and intends to seek regulatory clearance for OncoMate™ MSI in the United States and China.