LONDON (ShareCast) - (Sharecast News) - Omega Diagnostics has received its first purchase orders for its 'VISITECT CD4 350' cut-off test, it announced on Wednesday, adding that it was continuing to make progress with its 'VISITECT CD4 Advanced Disease' test.
The AIM-traded firm said it received its first purchase orders for its CE-Marked VISITECT CD4 350 cut-off test from distributors supplying into Indonesia, Moldova and Papua New Guinea.

As it had expected, the order quantities were low at the current stage, and reflected distributor intentions to seed their private business-to-business market channels in the initial stages.

"Nevertheless, this is an endorsement of the company's ability to develop and then commercialise this product through the regulatory processes in international markets," the board said in its statement.

"We expect to supply customers before the end of the current financial year."

As it had previously indicated, Omega said it saw Nigeria as being the single largest market for this version of the test and, while it was still awaiting its first order from Nigeria pending a performance evaluation, the board remained confident of the potential to deliver shareholder value from that opportunity.

Looking at the VISITECT CD4 Advanced Disease test, Omega said this version used a lower cut-off of 200 CD4 cells per cubic millimetre of blood, which it explained was a level at which patients immune systems were so weakened by HIV that they were at risk of infection by other life-threatening diseases.

The company said it had now achieved two further key milestones for the project - the successful completion of all internal verification studies by its development team, and the successful completion of an external performance evaluation of venous whole blood samples

Those studies were completed in line with their expected timelines and, to CE-Mark the Advanced Disease test, Omega said it was now only required to complete an external performance evaluation of finger prick blood samples.

Progress with those evaluations was currently tracking to plan, with a "significant" number of samples completed in Zimbabwe and India.

Results to date from both sites reportedly demonstrated that the test was performing in line with design goals, leaving the company confident that it would CE-Mark the product by the end of March.

Achieving that critical milestone was a further step towards completing the additional regulatory processes needed to supply the product into the non-governmental organisation community.

"We are pleased to have commercialised our VISITECT CD4 350 cut-off test in the current financial year and I remain confident with both the near term opportunity in Nigeria and the fact that our team has shown that they can take a developed product through complex registration processes to commercialisation," said Omega Diagnostics chief executive Colin King.

"In addition, the Advanced test continues to track against our timeline, which further demonstrates the significant improvements in our ability to deliver against our promises.

"This all bodes well for delivering meaningful revenues for CD4 in the next financial year."

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