Omega Diagnostics launches Visitect Covid-19 antigen test

The AIM-traded firm said the launch was the final stage in the commercial roll-out of the product, following successful CE mark approval in March.

It said the test was “easy to use” with throat and nasal swabs, or nasal only, and provided a visual read out in 10 minutes.

The Visitect test demonstrated “excellent” performance characteristics through independent multi-centre validation studies, the board said, with a sensitivity of 98.4% on samples with a cycle threshold of less than 20, and overall sensitivity of 85% on samples with cycle threshold values ranging from 9.8 to 43, while specificity was 97.8%.

Omega said it was in discussion with a number of potential commercial partners looking to order the test and distribute it on the company’s behalf.

On the subject of its contract with the Department of Health and Social Care (DHSC) to provide manufacturing capacity for Covid-19 lateral flow antigen tests, announced in February, Omega said it was now awaiting confirmation on which test had successfully passed the department’s performance evaluations.

The DHSC recently said it was in the process of assessing which of these tests were suitable for home-use, and thus obtain the appropriate self-test approval.

Once a suitable test is approved, the DHSC will license the test for Omega to manufacture, with the company noting it was not in control of that process, but would update shareholders once a test was confirmed.

While waiting to receive confirmation, Omega said it was supporting the government with additional cassetting and pouching services for other Covid-19 antigen lateral flow tests that were being deployed in the UK.

The company said it had made “good progress” towards establishing a lateral flow production capacity of about two million tests per week from its Alva facility in Scotland.

It said the completion of that capacity target, and full use of that capacity, remained dependent on the confirmation from the DHSC.

In the meantime, Omega was using its own capacity to produce its own tests and following the Visitect launch, said it expected, together with the test to be licensed from the UK government, to rapidly move towards use of its two million tests per week capacity.

At the site in Alva, the company was currently producing Visitect CD4 advanced disease tests, AbC-19TM Covid-19 rapid antibody tests and, following launch, the Visitect Covid-19 antigen test.

“We look forward to updating shareholders on our commercial discussions as they conclude,” said chief executive officer Colin King.

“I am pleased to say that we are now producing a wide range of our own tests from our Alva site and we look forward to being notified which test we will produce under the UK government contract, which will then see us move to production of up to two million tests a week.

“In the meantime, there is much ongoing activity; not only are we producing our own tests, but we are also producing AbC-19 rapid tests for the UK-RTC in anticipation of forthcoming orders as well as providing additional cassetting and pouching services to the UK government for other Covid-19 antigen lateral flow tests.”

At 1317 BST, shares in Omega Diagnostics were down 0.89% at 72.85p.