Omega hails nod from WHO

Medical diagnostics firm Omega has received World Health Organisation (WHO) prequalification for its Visitect CD4 Advanced Disease test, enabling the product to be used by UN agencies and “reach more people in those countries most in need”.

The Alva-based life sciences business said the product is the only currently available handheld lateral flow pointof-care test for identifying patients with advanced HIV who are at risk of potentially life-threatening opportunistic infections.

The offering will now be included in the WHO list of prequalified in-vitro diagnostics and can participate in the procurement processes of UN agencies.

Omega, which is part of the UK Rapid Test Consortium regarding Covid-19 to produce an antibody lateral flow self-test, praised the “key commercial milestone”. The step follows the supply agreement secured with the Clinton Health Access Initiative in April, which was to accelerate access of the CD4 test to lowincome, lower-middle income and upper-middle income countries as classified by the World Bank.

Omega chief executive Colin King welcomed the prequalification, which he said has allowed the US President’s

Emergency Plan for Aids Relief and UN agencies to get the test incorporated into their budgets for 2021, “meaning the test can reach more people in those countries most in need”. He praised the firm’s team “delivering on such an important milestone for the group, in such challenging economic conditions”.

Analysts at Finncap said obtaining prequalification is “a significant milestone” and opens up access fully to a £20 million point-of-care test market for which Visitect is the only offering of its kind.

They also said the approval helps position Omega “for further positive newsflow and consequent substantial growth”.