Alva-based Omega Diagnostics Group said on Friday it has received World Health Organisation (WHO) Prequalification for its Visitect CD4 Advanced Disease test for HIV.
Omega’s shares have risen more than 500% in the past 12 months to give it a stock market value of over £100 million amid its work in developing new tests with its partners for COVID-19.
Omega said the Visitect CD4 Advanced Disease test is “the only currently available handheld lateral flow point-of-care test for identifying patients with advanced HIV who are at risk of potentially life-threatening opportunistic infections.”
The Visitect CD4 Advanced Disease test will now be included in the WHO list of prequalified in vitro diagnostics (IVD) and becomes eligible to participate in the procurement processes of UN agencies.
Omega said: “This is a key commercial milestone for the company which follows the supply agreement secured with the Clinton Health Access Initiative, Inc in April 2020, which was to accelerate access of the test to low-income countries, lower-middle income countries and upper-middle income countries as classified by the World Bank.”
Omega CEO Colin King said: “We are extremely pleased to receive WHO Prequalification on our Visitect CD4 Advanced Disease test which has allowed PEPFAR 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.
“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.”