Omega Diagnostics makes good progress with 'VISITECT CD4' test

Medical diagnostics company Omega Diagnostics has successfully manufactured three validation batches of its ‘VISITECT CD4’ advanced disease test, it announced on Tuesday.

The AIM-traded firm said finished devices were tested in India, Zimbabwe and the UK, with results demonstrating that all three batches performed in line with its design goal parameters.

Those validation batches proved it could manufacture at scale, and were a requirement for obtaining a CE Mark.

As it had previously communicated, Omega was continuing to make good progress, with the board saying it expected to complete internal verification work and external performance evaluation of venous whole blood samples during February.

Omega said it had also made progress with planned external performance evaluations of finger prick samples.

In Zimbabwe, performance evaluation on finger prick blood started at the end of December and was currently estimated to be 50% complete, while in India, ethics approval was recently granted, with the evaluation expected to begin in February.

The board also noted the interest from organisations such as Unitaid that had recently launched an initiative to avert preventable deaths from advanced HIV disease.

“I am pleased to announce that we continue to deliver against our timeline for the VISITECT CD4 advanced disease test,” said Omega Diagnostics chief executive Colin King.

“I am also encouraged by the outlook for this product as key stakeholders continue to engage with us about the sizeable opportunity once we bring the test to market.”