The story previously stated Euroimmun has an Anti-SARS-CoV-2 ELISA test for IgA/IgG which was CE-marked but did not receive EUA from the FDA. It has been corrected to state there are two Anti-SARS-CoV-2 ELiSA tests, one for IgA and one for IgG. The IgA test has CE mark but not EUA. 360Dx regrets the error.
NEW YORK – The Welsh government and Life Sciences Hub Wales said on Thursday it plans to build a laboratory to create additional capacity for SARS-CoV-2 testing.
The laboratory, called the Lighthouse Lab, will be staffed by 200 people and be managed by PerkinElmer Genomics, which will also supply its COVID-19 testing kits.
PerkinElmer's tests for the coronavirus include the PerkinElmer New Coronavirus Nucleic Acid Detection Kit, as well as the EuroRealTime SARS-Cov-2 and the Anti-SARS-CoV-2 ELISA (IgG) tests offered by its Euroimmun subsidiary. All three have received Emergency Use Authorization from the US Food and Drug Administration.
PerkinElmer also offers its SuperFlex Anti-SARS-CoV-2 IgG kit and the PerkinElmer GSP/Delfia Anti-SARS-CoV-2 IgG kit, which have CE mark but have not received EUA from the FDA.
Euroimmun offers its Anti-SARS-CoV-2 ELISA (IgA), which is CE marked but has not received EUA yet.
The new lab, which will be located at Imperial Park in Newport, is part of a network of Light Labs established throughout Wales to increase SARS-CoV-2 testing. Construction of the lab is underway.
In June, Waltham, Massachusetts-based PerkinElmer said it had partnered with Public Health Wales to establish a national COVID-19 testing laboratory in Cardiff.