Omega Diagnostics (AIM:ODX)
announced this morning that it has CE-Marked Mologic Ltd's ('Mologic') lateral flow antibody test for COVID-19 for sale under its own VISITECT® brand.
The Mologic test is a point-of-care test that differentiates itself by testing for three antibodies - IgA, IgG and IgM - picking up positive patients at an earlier stage than most other tests.
The diagnostics firm said the test will be used in primary care settings, such as GP surgeries and for other professional use, and has been subject to successful independent validation by the Liverpool School of Tropical Medicine and St George's, University of London.
Mologic is currently applying for the World Health Organization emergency use listing for the antibody test. Omega will provide an update when Mologic receives a final decision.
Shares in Omega Diagnostics have improved from lows of 32p in July and were trading 0.43% higher at 58.5p following the news.
Today’s news makes Omega the legal manufacturer of the test. As a result, the Company will be able to manufacture up to 100,000 tests per week initially out of its Alva facility in Scotland, which is currently undergoing refurbishment to increase capacity as planned.
Omega will also commercialise the antibody test as a VISITECT® branded product. The company said it expects to announce the product's full marketing launch later this month.
Commenting on this morning’s news, Colin King, Chief Executive Officer of Omega, said:
“We are pleased to have reached this significant milestone of CE-Marking Mologic's lateral flow antibody test as we continue to support efforts to combat the effects of COVID-19.
This approval will allow us to commence in-country registrations and product evaluations. We also look forward to WHO emergency use approval in due course, which will open up opportunities for the test to access global tenders where this approval is required."
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