Immunodiagnostic Systems Hldgs PLC Automated assay to detect SARS-CoV-2 antibodies (7381P)
June 12 2020 - 2:00AM
UK Regulatory
TIDMIDH
RNS Number : 7381P
Immunodiagnostic Systems Hldgs PLC
12 June 2020
Immunodiagnostic Systems Holdings plc.
12 June 2020
Automated assay to detect SARS-CoV-2 antibodies
Immunodiagnostic Systems Holdings plc (IDS), a specialty
solution provider to the clinical laboratory diagnostic market,
announces a new automated COVID-19 IgG assay (The Test) has
achieved CE marking and is expected to be available for sale by the
end of this month.
The Test, which arises from the partnership between IDS and
Technogenetics, is designed to run on the automated IDS-iSYS
analyser. Today IDS and Technogenetics reached a commercial
agreement under which IDS shall sell, market and support this Test
on a global basis. For territories which do not accept CE marked
products, the requisite regulatory approvals will be required.
Test Overview
-- Detects specific IgG antibodies indicating past exposure to
the COVID-19 virus and immune response;
-- Quantitative test determines antibody concentration (titer), not just a 'yes/no' result;
-- Highly accurate with a sensitivity of 100%(1) and a
specificity of 99.4%(2) , thus meeting the performance criteria
specified by MHRA and the Royal College of Pathology, as well as
the most common international performance requirements;
-- Test results available within 25 minutes.
Unlike many COVID-19 serology assays currently available, this
Test is a quantitative assay. It can determine the antibody
concentration in patient serum, rather than giving a 'yes/no'
result for prior exposure to the virus. Although the clinical level
of functional immunity conferred by SARS-CoV-2 IgG antibodies has
not yet been determined, we believe quantitative tests may
ultimately be valuable in determining immunity status based on the
levels of antibody in the blood.
All steps of the Test are automated with no manual reagent
preparation required, ensuring minimal hands-on time for lab staff
and a high daily throughput.
IDS-iSYS analysers are already installed in over six hundred
laboratories worldwide, including many NHS hospitals. The majority
of these analysers are in territories which use the CE mark as the
basis for regulatory approval. Each system is capable of running
over 10,000 tests per month.
Jaap Stuut, CEO of IDS commented
"We are pleased that our collaboration with Technogenetics has
achieved the important milestone of CE-marking a quantitative,
fully automated SARS-CoV-2 antibody test running on the IDS-iSYS
analyser. We anticipate launching this assay throughout Europe
later this month. IDS has increased production levels of its
analysers, and we have sufficient inventory levels to facilitate
higher analyser placement levels driven by new customers wishing to
run the Test."
About IDS
IDS is a specialist in-vitro diagnostic provider to the clinical
laboratory market. IDS develops, manufactures and markets
innovative immunoassays and automated immuno-analyser technologies
to provide improved diagnostic outcomes for patients. IDS is
headquartered in Boldon, UK, and listed on the Alternative
Investment Market of the London Stock Exchange.
About Technogenetics
Technogenetics is an innovative company, based in Lodi, Italy,
that has been active for over 30 years in the areas of diagnostic
research and biotechnology. Since December 2015, Technogenetics is
part of the KHB Group, headquartered in Shanghai, and is engaged in
complex and ambitious challenges with the aim of offering the
market increasingly efficient and advanced diagnostic solutions.
KHB is listed on the Shenzhen Stock Exchange.
(1) Diagnostic sensitivity of the Test was calculated across 110
samples drawn from symptomatic Italian patients in March and April
2020. For blood samples taken 21 days or more after onset of
symptoms, diagnostic sensitivity was 100% (all samples positive).
The diagnosis of Sars-CoV-2 infection of those patients was
confirmed in nasopharyngeal swab samples by RT-PCR, specific for
the SARS-CoV-19 virus
(2) Initial data demonstrated an overall diagnostic specificity
of 99.4%, with 331 of 333 presumptive negative samples testing
negative with the Test. These negative samples came from both
pre-epidemic blood donors, as well as routine laboratory samples
taken during the epidemic, some with influenza or other potentially
interfering pathologies.
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
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END
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