LONDON (ShareCast) - (Sharecast News) - Omega Diagnostics has received World Health Organization (WHO) prequalification for its 'VISITECT CD4' advanced disease test, it announced on Friday.
The AIM-traded firm said the 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.

It said the VISITECT CD4 advanced disease test would now be included in the WHO list of prequalified in vitro diagnostics, and would become eligible to participate in the procurement processes of UN agencies.

WHO member states are encouraged to use the list for their respective procurement decisions, the board noted.

It said the prequalification process consisted of a "transparent, scientifically sound" assessment of products, which included an independent performance evaluation and site visits to the manufacturer to audit the quality system and product dossiers.

Omega said prequalification was a "key commercial milestone", and followed the supply agreement secured with the Clinton Health Access Initiative in April, which accelerated access to the test in low-income countries, lower-middle income countries and upper-middle income countries, as classified by the World Bank.

"We are extremely pleased to receive WHO prequalification on our VISITECT CD4 advanced disease test, which has allowed the US President's Emergency Plan for AIDS Relief (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," said chief executive officer Colin King.

"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."

At 0818 BST, shares in Omega Diagnostics were up 3.45% at 60p.

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