ALVA-headquartered biotechnology business Omega Diagnostics has moved one step closer to being able to market another of its key HIV-related products after gaining CE certification for its Visitect CD4 Advanced Disease test.
Earlier this month the firm secured the first orders for its related Visitect CD4 350 cut-off test, with its chief executive Colin King noting that the firm expected to grow its turnover to £20 million within five years once both kits had been brought to market.
Now it has received the CE mark for the advanced test, which indicates when medical intervention is required for patients in the advanced stages of HIV, Omega can press ahead with regulatory applications to the UNITAID-funded Expert Review Panel for Diagnostics and the World Health Organisation’s pre-qualification programme.
The intention is to market both products in the developing world, where treatment for HIV typically starts when CD4 counts fall to 350 as opposed to on diagnosis, as is generally the case in the western world.
“We are pleased to have reached the milestone of attaining the CE mark for our CD4 Advanced Disease test within the timeframe we previously set out,” Mr King said. “Together with our currently commercialised CD4 350 test, we intend to provide easy to use, clinically relevant CD4 testing to less advantaged communities around the world. We look forward to working with the global health community to bring this unique test to the market to make a positive impact on the lives of many people living with HIV.”
The 350 test, which has been purchased by distributors in Indonesia, Moldova and Papua New Guinea, indicates when HIV patients should start receiving antiretroviral drugs. The advanced test indicates when those drugs should be temporarily withdrawn so medication for another illness can be administered.
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