Omega Diagnostics wins green light for tests in Chinese labs after coronavirus delays

Life sciences firm Omega Diagnostics has received Chinese regulatory approval for the laboratory version of its food detective test, as its venture into the Nigerian market suffers delays.

The coronavirus has caused delays to Omega Diagnostics in Nigeria and Kenya.

The Alva business, which specialises in tests for allergies, infectious diseases and food intolerance, has been given the green light by the National Medical Products Administration – formerly the China Food and Drug Administration – for laboratory use of the kits to detect potentially harmful antibodies in food.

Approval was held up by around two months due to the coronavirus outbreak.

Chief executive Colin King said: “This is an excellent reward for all the hard work put in by both our and our partner’s teams, especially in these challenging times.

“We will now focus our efforts to achieving the self-test approval in China in conjunction with our partner.”

The coronavirus has also delayed Omega’s first foray into the Nigerian market, where it has been granted government approval to deploy its HIV tests, with the initial shipment now likely to be pushed into next year.

The Clackmannanshire group had received initial orders from its distribution partner in Nigeria for 250,000 HIV testing kits.

‘Large market opportunity’

In a market update the Aim-quoted business said: “We remain confident that this demand will materialise and that Nigeria remains a large market opportunity. It is possible that there may be further delays in the short term due to the lockdown procedures that are now being introduced into parts of Africa.”

Omega has shipped and invoiced more than 15,000 testing kits in the year to 31 March. It estimates the delay to the Nigerian deployment, along with the coronavirus impact on certain countries due to deploy its advanced disease test, has deferred demand by around 50,000 tests for each version into the current financial year.

The group forecasts underlying earnings for the year to the end of March to be between £700,000 and £750,000, broadly in line with market expectations.

Omega added that it has selected Kenya as the location to conduct a World Health Organisation performance evaluation for its Visitect CD4 advanced disease test and is currently awaiting ethics approval.

New applications have been put on hold by Kenya authorities since the coronavirus outbreak, however Omega hopes that it will be able to start and complete these studies this year.

Analysts at FinnCap said: “Whilst the potential for further disruption due to Covid-19 is possible, there is no doubt that there remains a need for Visitect, with a potential annual demand for around six million Visitect CD4 tests.”

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