Immunodiagnostic Systems Hldgs PLC FDA EUA for automated IgG SARS-CoV-2 assay (7138T)

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RNS Number : 7138T

Immunodiagnostic Systems Hldgs PLC

29 March 2021

Immunodiagnostic Systems Holdings plc.

29 March 2021

IDS receives FDA Emergency Use Authorization for automated assay to detect IgG SARS-CoV-2 antibodies

Immunodiagnostic System Holdings plc ("IDS"), a specialty solution provider to the clinical laboratory diagnostic market, announces that it has concluded an agreement with its partner Technogenetics ("TGS"), whereby TGS will supply IDS with a fully automated IDS SARS-CoV-2 IgG test (the "Test") to run on the IDS-iSYS analyzer, for sales into the USA.

The Test has received the US Food and Drug Administration's ("FDA") Emergency Use Authorisation ("EUA"). As a result, IDS is now able to sell the Test to laboratories in the USA for clinical testing purposes.

The Test has been developed for identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The Test exceeds the FDA`s sensitivity and specificity requirements for laboratory run serology tests. It provides 100% Positive Percent Agreement after 7 days of diagnosis by RT-PCR and 99.6% Negative Percent Agreement for pre-endemic samples.

The Test does not cross react with other strains of coronavirus, significantly reducing the risk of false positives.

All steps of the Test are automated with no manual reagent preparation required, ensuring a high daily throughput. Test results are available within 25 minutes and can be run on any of the IDS-iSYS analysers which are already installed in numerous hospitals and laboratories in the USA. Each iSYS is capable of running over 10,000 tests per month.

Tests will be available for sale at the end of April. By providing our customers with this fully automated and flexible laboratory solution, IDS has the potential to increase our testing volumes in the US market, as well as attract new customers to the IDS platform.

Required Notice by FDA:

This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. -- 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

IDS COVID-19 PRODUCT PORTFOLIO

In addition to the new Test available in the USA, IDS provides an extensive panel of tests for sale in Europe and other countries which accept the CE mark accreditation. This panel of COVID-19 solutions includes:

   1.    Antibody testing to detect recent or prior infection with SARS-CoV-2 

-- High volume, fully automated tests to quantify IgG or detect IgM antibodies. These tests run in a laboratory setting on IDS's proprietary automated analyser, the IDS-iSYS.

-- ELISA based tests which can be used to detect IgG or IgM antibodies which are suitable for small to medium size laboratories.

-- Point of care IgG and IgM rapid antibody test which can be used in a community setting by a trained healthcare professional without the need for specialised laboratory equipment.

   2.    Antigen testing to detect current patient infection with SARS-CoV-2 

IDS offers two point of care antigen tests, which utilise a nasopharyngeal swab to obtain a patient sample. These tests can be used in a community setting by a trained healthcare professional without the need for speciality laboratory equipment.

More details on these tests are available at www.idsplc.com

For further information:

   Immunodiagnostic Systems Holdings plc                   Tel: [phone] 

Jaap Stuut, Chief Executive Officer

Paul Martin, Group Finance Director

Peel Hunt LLP Tel: [phone]

James Steel

Oliver Jackson

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March 29, 2021 02:00 ET (06:00 GMT)