On June 9, 2020 Promega Corporation reported CE marking for the OncoMate MSI Dx Analysis System (OncoMate MSI) as a new in vitro diagnostic (IVD) medical device in Europe (Press release, Promega, JUN 9, 2020, View Source [SID1234560942]). OncoMate MSI is a PCR-based, validated gold standard for determining microsatellite instability (MSI) status in solid tumors.1,2,3 It offers analytical sensitivity and unsurpassed specificity with a short turn-around time.4,5

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

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.9

OncoMate MSI uses the most sensitive panel of markers for MSI status detection, as included in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 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.10

"Promega MSI technology demonstrates our commitment to developing precise and reliable tools for life scientists around the world," said Heather Tomlinson, Director of Clinical Diagnostics at Promega Corporation. "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."

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.

To learn more about OncoMate MSI Dx Analysis System, visit: www.promega.com/OncoMateCEIVD

About OncoMate MSI Dx Analysis System

OncoMateTM MSI Dx Analysis System encompasses a complete workflow for MSI determination from DNA extraction to data analysis, offering an easy to use and standardized system. It includes the same validated and endorsed loci as the Promega Research Use Only MSI Analysis System Version 1.2 with the new advantages of a shorter turn-around time and GoTaq MDx DNA polymerase. OncoMate MSI is a fluorescent, multiplex PCR-based test to detect DNA sequence length changes in microsatellite regions of tumor cell DNA relative to the same regions from the patient’s normal cells thereby indicating microsatellite instability. OncoMate MSI targets seven microsatellite markers: five mononucleotide-repeat markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) and two pentanucleotide-repeat markers (Penta C and Penta D). These mononucleotide-repeat markers are analyzed to determine MSI status and were selected for high sensitivity and specificity to alterations in repeat lengths in samples containing mismatch repair defects. MSI is a form of genomic instability caused by insertion or deletion of additional bases into DNA microsatellites, regions of repeating bases distributed throughout the human genome. During DNA replication, failure of the mismatch repair system to correct these errors causes MSI.