Omega Diagnostics announced receipt of the draft performance evaluation report for the ‘VISITECT CD4’ advanced disease rapid test on Wednesday, issued by the World Health Organisation (WHO).
The AIM-treaded firm confirmed the sale of its CD4 business to Accubio in August, and under that agreement, it expected to receive up to an additional £4m contingent on the successful outcome of the clinical study in Kenya, required to maintain the test’s WHO prequalification status.
It said receipt of the draft performance evaluation was an “important milestone” in completing the prequalification process, and in releasing the deferred consideration funds.
The company said the VISITECT CD4 test was evaluated at the Kenya Medical Research Institute in Kisumu on behalf of the WHO, where 300 specimens were analysed.
It said the report concluded that the test showed high sensitivity of 96% and a specificity of 96% from whole blood specimens, and high sensitivity of 95% and a specificity of 97% using capillary blood specimens.
Repeatability and reproducibility on specimens with reference values of less than 150 or greater than 250 CD4+ T-cells per microlitre was 100%.
Omega said the results were in line with its expectations.
The company now had until 3 November to review and comment on the draft report and the results submitted.
A summary of the performance evaluation would then be included in the WHO prequalification public report if the product successfully met all WHO prequalification requirements.
“We are extremely pleased to receive this draft report, detailing that the test has shown high diagnostic accuracy,” said chief executive officer Jag Grewal.
“Whilst we have no visibility of the WHO prequalification requirements, it is encouraging to formally receive these 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 £4.0m of deferred consideration.”
At 0842 BST, shares in Omega Diagnostics Group were up 21.52% at 2.8p.
Reporting by Josh White at Sharecast.com.
