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Omega Diagnostics CE-marks 'VISITECT CD4' test for HIV patients

By Josh White

Date: Monday 18 Mar 2019

Omega Diagnostics CE-marks 'VISITECT CD4' test for HIV patients

(Sharecast News) - Medical diagnostics company Omega Diagnostics announced on Monday that it has CE-marked its 'VISITECT CD4' advanced disease test for monitoring people living with HIV.
The AIM-traded firm said the test utilised a cut-off of 200 CD4 cells per cubic millimetre of blood - a level at which patients' immune systems were so weakened by HIV that they were at risk of infection by other life-threatening diseases.

It said the technical file supporting the CE-mark would form the basis of the additional regulatory approvals that the company would seek through the UNITAID-funded 'Expert Review Panel for Diagnostics' (ERPD), hosted by the Global Fund to Fight AIDS, Tuberculosis and Malaria.

The ERPD outcome was a time-limited, risk-based recommendation on eligibility for procurement, while the company underwent the World Health Organisation prequalification programme.

It said that programme aimed to ensure that clinical diagnostics, medicines and vaccines met global standards of quality, safety and efficacy, in order to optimise the use of health resources and improve health outcomes.

"We are pleased to have reached the milestone of attaining the CE-mark for our VISITECT CD4 advanced disease test within the timeframe we previously set out," said Omega Diagnostics chief executive officer Colin King.

"Together with our currently commercialized VISITECT 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."


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