NEW YORK ─ Alva, UK-based Omega Diagnostics said on Thursday that is has received CE marking for Mologic's COVID-19 lateral flow antibody test and will market the assay under Omega's Visitect brand.
The lateral flow antibody test developed by Bedford, UK-based Mologic is a point-of-care assay that detects IgA, IgG, and IgM antibodies. The test, which was independently validated by the Liverpool School of Tropical Medicine and St George's and the University of London, will be implemented in primary care settings, such as general practitioner surgeries, Omega said.
Omega will manufacture up to 100,000 tests per week initially in its Alva, Scotland facility, where the firm is expanding capacity. Omega said it expects to launch the test later this month.
Omega and Mologic inked a manufacturing deal for the SARS-CoV-2 test earlier this year.
Mologic is applying for a World Health Organization emergency use listing for the lateral flow antibody test.
Colin King, CEO of Omega, said in a statement that CE marking will enable it to commence in-country registrations and product evaluations, and WHO emergency use approval would "open up opportunities for the test to access global tenders where this approval is required."
A separate rapid point-of-care SARS-CoV-2 antibody test developed by the UK Rapid Test Consortium (UK-RTC) ─ founded in April by Omega, Abingdon, BBI Solutions, CIGA Healthcare, and the University of Oxford ─ has also received the CE mark.
Mologic said in May that it is also collaborating with self-test designer BioSure to produce a SARS-CoV-2 antibody self-test.