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Immunodiagnostic Systems gets emergency FDA approval for Covid-19 test
29th Mar 2021 12:24
(Sharecast News) - Clinical laboratory diagnostic technology company Immunodiagnostic Systems (IDS) has reached an agreement with its partner Technogenetics (TGS), it announced on Monday, under which TGS would supply it with a fully-automated SARS-CoV-2 IgG test, to run on its 'IDS-iSYS' analyser, for sales in the United States.
The AIM-traded firm said the test had received emergency use authorisation from the US Food and Drug Administration (FDA).
As a result, IDS would now be able to sell the test to laboratories in the US for clinical testing purposes.
The test was developed for identifying individuals with an adaptive immune response to SARS-CoV-2 - the virus that causes Covid-19 - indicating recent or prior infection.
IDS said the test exceeded the FDA's sensitivity and specificity requirements for laboratory-run serology tests.
It provides 100% positive percent agreement after seven days of diagnosis by RT-PCR, and 99.6% negative percent agreement for pre-endemic samples, the board reported.
The test did not cross-react with other strains of coronavirus, it added, "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," IDS said in its statement.
"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 US."
Each iSYS was capable of running more than 10,000 tests per month, according to IDS.
"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."
At 0958 GMT, shares in Immunodiagnostic Systems Holdings were up 5.26% at 200p.
The AIM-traded firm said the test had received emergency use authorisation from the US Food and Drug Administration (FDA).
As a result, IDS would now be able to sell the test to laboratories in the US for clinical testing purposes.
The test was developed for identifying individuals with an adaptive immune response to SARS-CoV-2 - the virus that causes Covid-19 - indicating recent or prior infection.
IDS said the test exceeded the FDA's sensitivity and specificity requirements for laboratory-run serology tests.
It provides 100% positive percent agreement after seven days of diagnosis by RT-PCR, and 99.6% negative percent agreement for pre-endemic samples, the board reported.
The test did not cross-react with other strains of coronavirus, it added, "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," IDS said in its statement.
"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 US."
Each iSYS was capable of running more than 10,000 tests per month, according to IDS.
"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."
At 0958 GMT, shares in Immunodiagnostic Systems Holdings were up 5.26% at 200p.