Automated IgM assay to detect SARS-CoV-2

Immunodiagnostic Systems Holdings plc.

13 August 2020

Automated assay to detect SARS-CoV-2 IgM antibodies

Immunodiagnostic Systems Holdings plc (IDS), a specialty solution provider to the clinical laboratory diagnostic market, announces a new automated SARS-CoV-2 IgM assay (The Test) has achieved CE marking and is expected to be available for sale in the UK, European Union and other countries which accept the CE mark as the basis of regulatory approval in September.

The Test, which arises from the partnership between IDS and Technogenetics, is designed to run on the automated IDS-iSYS analyser. For territories which do not accept CE marked products, the requisite regulatory approvals will be required.

The presence of IgM antibodies to a virus is generally more short-lived than that of IgG antibodies. Thus, testing both antibody classes often helps the laboratory and clinician differentiate between a recent and an historic infection. During the outbreak of 2003-SARS and 2016-Zika, IgM / IgG antibody detection was used as one of the recommended diagnostic methods.

Test Overview

· Detects specific IgM antibodies indicating recent exposure to the COVID-19 virus and that the immune system has started responding to the virus;

· When used in conjunction with IDS' automated SARS-CoV-2 IgG assay, will help laboratories to differentiate between the IgG and IgM antibody isotypes present in a sample;

· Test results available within 30 minutes.

These tests can play a critical role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have been exposed to the SARS-CoV-2 virus and may have developed an immune response. Healthcare authorities have generally requested separate detection of IgM and IgG antibodies, as this can cover a wider period of antibody production, and each isotype may contribute complementary information as to the infection status.

Jaap Stuut, CEO of IDS commented:

"The ability to test IgG and IgM antibodies simultaneously from the same sample tube, on the same automated analyzer, will provide a valuable diagnostic complement to RT-PCR tests used to detect the COVID-19 virus."

For further information:

Immunodiagnostic Systems Holdings plc Tel: +44 (0) 191 519 6111

Jaap Stuut, Chief Executive Officer

Paul Martin, Group Finance Director

Peel Hunt LLP Tel: +44 (0) 20 7418 8900

James Steel

Oliver Jackson