Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces that it has CE-Marked its VISITECT® CD4 Advanced Disease test for monitoring people living with HIV.
The VISITECT® CD4 Advanced Disease test utilises a cut-off of 200 CD4 cells/mm³ of blood, a level at which patients’ immune systems are so weakened by HIV that they are at risk of infection by other life-threatening diseases.
The technical file supporting the CE-Mark will form the basis of the additional regulatory approvals that the Company will 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 is a time-limited, risk-based recommendation on eligibility for procurement whilst the Company undergoes the World Health Organisation Prequalification programme. This programme aims to ensure that clinical diagnostics, medicines and vaccines meet global ...
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