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OncoMate™ Microsatellite Instability Diagnostic Test Expands UK Testing Options for Lynch Syndrome

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A new CE-IVD marked diagnostic test for microsatellite instability (MSI) in solid tumors, the OncoMate™ MSI Dx Analysis System (OncoMate™ MSI) by Promega, offers UK clinicians a new option for testing for Lynch Syndrome. UK NICE guidelines (DG27) for Lynch Syndrome testing include the use of PCR-based testing methods such as OncoMate™ MSI to determine MSI status in patients to guide treatment and advise surveillance or testing for the wider family. OncoMate™ MSI builds on the success of the Research Use Only (RUO) product (MSI Analysis System, Version 1.2) which has been adopted by UKAS accredited laboratories for the diagnosis of Lynch Syndrome in the UK for over a decade.

MSI status can also inform clinicians prior to treatment, acting as an independent biomarker to predict the efficacy of certain Immuno-Oncology therapies against solid tumors in the clinic (such as anti-PD1 antibody therapy). Patients with MSI-high (MSI-H) tumors typically respond well to anti-PD1 therapy.

“MSI testing is of critical importance to ensure the efficacy of anti-PD1 therapy for solid tumours like Colorectal Cancer,” says Professor Manuel Salto-Tellez (MD-LMS, FRCPath, FRCPI) Clinical Consultant Pathologist at the Belfast Health and Social Care Trust and Director of the Precision Medicine Centre.

“We welcome the addition of a CE-IVD marked testing tool as we move to the new IVD-R regulations in 2022.”

In the U.S., MSI-H has been granted status as a pan-tumor biomarker for anti-PD1 therapy regardless of tumor type. An example of an anti-PD1 therapy is Merck’s Keytruda®.

Promega Corp announced the launch of the CE-IVD marked OncoMate™ MSI Dx Analysis System (OncoMate™ MSI) as a new in vitro diagnostic (IVD) medical device on Tuesday 9 June across 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. OncoMate™ MSI uses the most sensitive panel of markers for MSI status detection, as included in the European Society for Medical Oncology (ESMO) guidelines.