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Omega Diagnostics Receives CE Mark for CD4 HIV Monitoring Test

NEW YORK (360Dx) – Omega Diagnostics Group said today that it has received CE marking for its Visitect CD4 Advanced Disease test for monitoring people living with HIV.

The test uses a cut-off of 200 CD4 cells/mm³ of blood, the point at which patients' immune systems are so weakened by HIV that they are at risk of infection by other life-threatening diseases, Omega said.

Colin King, CEO of the Scottish diagnostics firm, said in a statement that it intends "to provide easy-to-use, clinically relevant CD4 testing to less advantaged communities around the world."

Omega said that the technical file supporting the CE mark will form the basis of additional regulatory approvals that it anticipates seeking through the Expert Review Panel for Diagnostics (ERPD), which is funded by the Unitaid global health initiative and hosted by the Global Fund to Fight AIDS, Tuberculosis, and Malaria.

Omega said that an ERPD approval would entail a time-limited, risk-based recommendation on eligibility for procurement, while it undergoes the World Health Organization prequalification program — an initiative that aims to ensure that clinical diagnostics, medicines, and vaccines meet global standards of quality, safety, and efficacy.