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FDA Clears Promega Microsatellite Instability Test System

NEW YORK – Promega announced on Wednesday that the US Food and Drug Administration has cleared its OncoMate MSI Dx Analysis System. The microsatellite instability diagnostic can now be used to screen for Lynch syndrome in colorectal cancer patients, the Madison, Wisconsin-based firm said.

The Promega OncoMate MSI Dx kit is a fluorescent, multiplex PCR-based fragment-sizing test targeting mononucleotide repeat markers. Instability is determined by fragment size analysis on a capillary electrophoresis instrument following PCR amplification of DNA from a patient's normal and tumor tissue samples, according to the firm's website.

The test can be performed using a portion of a single formalin-fixed, paraffin-embedded section and yields results in approximately 10 hours.

Microsatellite instability, or MSI, status is used to screen for Lynch syndrome, a hereditary condition involving mutations in certain DNA repair genes that leads to increased risk of developing cancer.

Universal screening of all colorectal tumors for MSI status is recommended in guidelines from the National Comprehensive Cancer Network, as well as by the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology, Promega said.

"Tools that enable the accurate determination of the MSI status of colorectal cancer tumors are vital for patients and their families," said James Eshleman, professor of pathology and oncology at Johns Hopkins University School of Medicine. "An FDA-cleared MSI diagnostic kit gives patients, oncologists, and pathologists in the US access to technology that, for the last 15 years, has been a gold standard around the world for studying MSI status in solid tumors," he added.

Promega announced it would seek FDA clearance for its MSI assay in 2017, and later announced a collaboration with Merck to develop a companion diagnostic for pembrolizumab (Keytruda). The firm persisted in its plans through the pandemic year and most recently also agreed to develop its OncoMate MSI as a companion diagnostic test for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.

OncoMate MSI is also CE-IVD marked in the UK and select European countries, Promega said. The firm intends to seek regulatory clearance in China, where the Promega MSI technology has received innovation status and priority review by the National Medical Products Administration.

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