A new CE-IVD marked diagnostic test for microsatellite instability (MSI) in solid tumours, 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 tumours in the clinic (such as anti-PD1 antibody therapy). Patients with MSI-high (MSI-H) tumours typically respond well to anti-PD1 therapy1.
“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-tumour biomarker for anti-PD1 therapy regardless of tumour 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.2–4 It offers analytical sensitivity and unsurpassed specificity with a short turn-around time.5,6 OncoMate™ MSI uses the most sensitive panel of markers for MSI status detection, as included in the European Society for Medical Oncology (ESMO) guidelines.
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