By Kristy Dorsey

Omega Diagnostics has expanded the market reach for one of its key HIV tests after receiving prequalification status from the World Health Organisation (WHO).

Prequalification allows UN agencies to incorporate the cost of Omega’s CD4 test, known as Visitect, into their budgets for next year. The WHO estimates the annual market for HIV diagnostics to be in the region of 12 million tests, about half of which are for point of care (POC) tests such as those from Omega.

The Scottish company, which is also involved in various Covid-19 related projects, has two main tests to detect the level of CD4 white blood cells in a patient: Visitect 350 for those whose HIV is relatively under control, and Visitect Advanced for those whose disease is more severe, putting them at risk of other opportunistic infections. The WHO prequalification applies to the latter.

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“This has been an extensive process, and I’m proud of the team delivering on such an important milestone for the group, in such challenging economic conditions,” said Colin King, chief executive of Alva-based Omega.

Visitect Advanced is currently the only available handheld lateral flow POC test for identifying patients with advanced HIV. Working much like a home pregnancy test, it is of particular use in areas where clinical testing facilities are in short supply.

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The approval follows the announcement in April of a deal between Omega and the Clinton Health Access Initiative (CHAI) to supply up to 500,000 Visitect tests into what the World Bank defines as “eligible countries”. That agreement runs until December 2021.

In terms of its work on Covid-19, Omega is part of the UK Rapid Test Consortium (UK-RTC) that is developing an at-home test for coronavirus antibodies. It is also involved in a second partnership with Bedfordshire-based Mologic that has produced as lab-based Covid-19 antibody test that has received the CE mark of approval for use in Europe.