CLACKMANNANSHIRE biotechnology business Omega Diagnostics expects its turnover to rise to over £50 million in the next five years after beginning the commercialisation of one of its key HIV-related products.

The business, which is headquartered in Alva, makes diagnostic tests that focus on HIV, allergies and food intolerances, but only the latter part of the business currently generates revenues.

Chief executive Colin King said he expects the £8 million the company makes from selling food intolerance kits to increase to between £15m and £20m within five years, with its allergies arm expected to contribute around £15m within the same timeframe.

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With the company just securing its first orders for a test that determines whether treatment for HIV is required, however, Mr King said he would be “disappointed” if that segment of the firm was “not up to the £20m mark” within five years.

Omega has developed the Visitect CD4 350 cut-off test, which indicates when CD4 cell counts in HIV patients have fallen low enough for antiretroviral drugs to be become necessary, over the last few years.

It has just secured initial orders for the product from distributors in Indonesia, Moldova and Papua New Guinea and expects to be able to start marketing its related Visitect CD4 Advanced Disease test by the end of this year.

It has also received ethics approval for the 350 cut-off test from the National Health Research Ethics Committee of Nigeria, with the hope of selling the kit there in the near future.

“Each country has a different way of managing HIV patients,” Mr King said. “In the western world, whenever someone is diagnosed they are immediately put on antiretroviral drugs, but ours is a point-of-care test that is designed for rural areas in the developing world.

“The 350 test is used as a device to prioritise the administration of drugs – if the cell count falls below 350 cells per cubic millilitre that would be a trigger point.

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“We’ve got about 25 countries that we are targeting around the world for the 350 test. Nigeria is our biggest opportunity because of the size of the country, the number of HIV patients in the country and how they manage those patients.”

Unlike the 350 cut-off test, Omega’s advanced disease kit, which detects when the CD4 cell count falls below 200, is not designed to indicate when drugs should be administered to patients but rather when they should be withdrawn.

“Patients below a level of 200 cells per cubic millilitre have a very weak immune system and have a high risk of contracting other diseases, such as tuberculosis, and it is those diseases that will typically kill them rather than HIV,” Mr King explained. “It’s been found that if you’re taking antiretroviral treatment when your immune system is so low it’s not so effective. It’s better to take patients off the antiviral drugs, treat the other disease, and once that is treated put them back onto the HIV drugs and they will have a better chance of survival.”

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Omega has completed internal testing of the advanced disease kit and expects the final stage of the external process to finish in the next few weeks. That will allow the company to register the test with the Medicines and Healthcare Products Regulatory Agency (MHRA) - which will enable it to sell it into some countries – as well as with the World Health Organization (WHO), which would enable it to sell the kit to aid agencies.

Mr King said it may be possible to fast-track the latter process because a number of non-governmental organisations have indicated that they would be keen to use the kit.

“A fast-track process is used in certain circumstances where the product will have a positive impact on people’s lives,” he said. “[The WHO] have indicated that they’ll engage in that process once we have [MHRA approval] and we expect that by the end of this year we’ll get purchase orders from aid agencies.”