(Alliance News) - Omega Diagnostics Group PLC on Wednesday said it has received positive data from the World Health Organisation regarding the evaluation of its Visitect CD4 Advanced Disease Rapid test.
The Scotland-based medical diagnostics company reported that WHO's draft report said its test has shown high diagnostic accuracy.
Omega shares trading 25% higher at 2.88 pence each in London on Wednesday late morning.
The Visitect CD4 Advanced Disease test is a rapid lateral flow assay, designed to identify people at high risk of opportunistic infections like tuberculosis and cryptococcal meningitis.
300 specimens were analysed as part of WHO's evaluation conducted at the Kenya Medical Research Institute in Kisumu, Kenya. The report concluded the test showed high sensitivity of 96%, as well as a specificity of 96% from whole blood specimens.
The evaluation receipt is an important milestone for Omega, who confirmed the sale of its CD4 business to Accubio Ltd in August 2022, and expects to receive GBP4.0 million contingent upon the successful outcome of its clinical study in Kenya and subsequent completion of the pre-qualification process.
Omega now has until November 3, 2022 to review and comment on the draft report and the results submitted.
A summary of the performance evaluation report will then be included in the WHO pre-qualification public report if the product meets all requirements.
Chief Executive Officer Jag Grewal said it was encouraging to formally receive positive results.
"If the Visitect CD4 Advanced Disease test successfully meets all WHO pre-qualification requirements, it will continue to be made available for sale by Accubio and the company will receive the full GBP4.0 million of deferred consideration," he added.
By Holly Beveridge; hollybeveridge@alliancenews.com
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