Omega Diagnostics receives WHO prequalification for HIV test
has received World Health Organisation prequalification for its VISITECT® CD4 test, the only currently available handheld lateral flow point-of-care test for identifying patients with advanced HIV at risk of potentially life-threatening infections.
Omega said the test will now be included in WHO’s list of prequalified in vitro diagnostics (IVD) and becomes eligible to participate in the procurement processes of UN agencies.
The medical diagnostics firm acknowledged that all WHO Member States are encouraged to use the WHO list of prequalified IVDs for their respective procurement decisions.
An assessment will be conducted as part of the prequalification process will include an independent performance evaluation and audit of the quality system and product dossiers.
Shares in Omega Diagnostics have improved from lows of 32p in July and were trading 13.79% higher at 66p on Friday morning following the announcement. Worth noting today’s rise
The news follows a supply agreement that Omega secured with the Clinton Health Access Initiative in April 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 said the prequalification represents a “key commercial milestone” for the Company. Commenting on this morning’s news Colin King, Chief Executive of Omega commented:
"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."
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