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Promega Nabs CE Mark for Microsatellite Instability IVD

NEW YORK – Promega said on Tuesday that it has received CE marking for its OncoMate MSI Dx Analysis System, allowing it to make the test available as an in vitro diagnostic medical device in Europe.

OncoMate MSI is a PCR-based assay that measures microsatellite instability status in tissue samples from solid tumors. According to Promega, the kit offers high analytical sensitivity and specificity with a short turnaround time.

Initially a biomarker used mostly in the context of Lynch-associated colorectal cancers, MSI has since emerged as a tool to guide the use of cancer immunotherapies across a wide variety of tumors after the US Food and Drug Administration's groundbreaking 2017 approval of pembrolizumab (Merck's Keytruda) for MSI-high or DNA mismatch repair-deficient solid tumors regardless of their location in the body.

In approving the new drug indication, FDA did not at the time approve a specific companion test, but Promega announced shortly afterward that it would be seeking clearance for its platform, along with relevant approvals and certifications to sell the test in Europe and Asia.

In February 2019, Japan's Ministry of Health, Labor, and Welfare approved the Promega MSI test as a companion diagnostic for pembrolizumab, with the test being distributed in Japan by Kyoto-based Falco Biosystems. Promega also saw the assay granted innovation designation by the Chinese National Medical Products Administration (NMPA) last year, easing its path toward classification as an IVD in that country.

And last November, the company said that it was collaborating with Merck to bring the test through FDA review as an official CDx.

Heather Tomlinson, Promega's director of clinical diagnostics, said in a statement that the company hopes that new CE marking and availability of its assay can help make MSI testing more broadly accessible to European laboratories.

"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," Inserm research director Richard Hamelin said in a statement accompanying the Promega announcement.

"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," he added.