Immunodiagnostic Systems Hldgs PLC FDA EUA for automated IgG SARS-CoV-2 assay (7138T)
March 29 2021 - 1:00AM
UK Regulatory
TIDMIDH
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: +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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