HomeFDA UpdatesFDA Clears Promega OncoMate™ MSI Dx Analysis System

FDA Clears Promega OncoMate™ MSI Dx Analysis System

Oncologists and pathologists in the United States can now access a new in vitro diagnostic (IVD) test that screens for Lynch syndrome in patients with colorectal cancer.

The OncoMate™ MSI Dx Analysis System (OncoMate™ MSI), developed by Promega, has been cleared by the US Food and Drug Administration (FDA) as an IVD medical device to determine microsatellite instability (MSI) status in colorectal cancer tumors. This is the industry’s first and only PCR-based diagnostic kit for MSI characterization that is FDA-cleared for use in labs across the United States.

Lynch Syndrome

Lynch syndrome is an inherited condition that increases the risk of developing colorectal and other cancers. It is the most common inherited cause of colorectal cancer. An estimated 1 in 279 people have Lynch syndrome but 95% do not know they have it. High-frequency MSI (MSI-H) is an indication that patients should be referred for further genetic testing for Lynch syndrome.

“Tools that enable the accurate determination of the MSI status of colorectal cancer tumors are vital for patients and their families,” says James Eshleman, MD, Ph.D., Professor of Pathology and Oncology, Johns Hopkins University School of Medicine. “An FDA-cleared MSI diagnostic kit gives patients, oncologists, and pathologists in the U.S. access to technology that, for the last 15 years, has been a gold standard around the world for studying MSI status in solid tumors.”

MSI Status

DNA is constantly copying itself. MSI is a form of genomic instability caused when too many or too few repeating bases, called microsatellites, occur during DNA replication and the body’s mismatch repair system fails to correct these errors. MSI status is used to screen for Lynch syndrome. Since Lynch syndrome is hereditary, this information is crucial not only for the patient, but for family members as well.

Universal screening of all colorectal tumors for MSI status is recommended in guidelines by the National Comprehensive Cancer Network (NCCN®) as well as the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and American Society of Clinical Oncology (ASCO).

Promega OncoMate™ MSI Technology

Promega OncoMate™ MSI is based on the company’s “for research use only” technology, the first commercially manufactured kit to detect MSI status and the leading standard test for MSI status detection in research laboratories worldwide. Promega MSI technology has been used extensively in clinical research for more than 15 years and is supported by over 140 peer-reviewed publications.

The Promega five MSI loci are often the comparative benchmark used by other companies and organizations for determining MSI status and align with guidelines including the National Cancer Institute (NCI) – Revised Bethesda Guidelines for Hereditary Nonpolyposis Colorectal Cancer (Lynch syndrome) and Microsatellite Instability.

OncoMate™ MSI Features:

  • Fluorescent, multiplex PCR-based fragment-sizing test
  • High sensitivity and specificity – targets five mononucleotide repeat markers.
  • Short turn-around time – from FFPE sample to answer in as little as 10 hours.
  • Conserves precious samples MSI results with ≤1 FFPE section.

Promega MSI Global IVD Portfolio

OncoMate™ MSI is CE-marked IVD medical device in the United Kingdom and select European countries. Promega also intends to seek regulatory clearance for a Promega MSI IVD in China where the Promega MSI technology received innovation status and priority review by the National Medical Products Administration (NMPA).

To learn more about the OncoMate™ MSI Dx Analysis System, visit here.


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