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New Regulatory Agency In Africa Aims To Facilitate Approval Of CD4 Diagnostic Tests

Noting the WHO has called for 15 million people living with HIV to be receiving antiretroviral therapy (ART) by 2015 and new WHO HIV treatment guidelines say ART should be prescribed when patients’ CD4 cell counts reach 500 cells/mm3, a higher threshold than previously recommended, The Guardian’s “Global Development Professionals Network” writes, “CD4 counts are therefore pivotal to reach the UNAIDS target, particularly in sub-Saharan Africa where HIV prevalence is high, but the test [to determine CD4 count] isn’t widely available in countries with poor health care.” While “[t]he introduction of decentralized point-of-care tests, which can be used in resource-constrained settings by low-skilled health workers, could significantly increase coverage … [t]he trouble is that such point-of-care diagnostics are something of a blind spot when it comes to regulation,” the newspaper adds. “In a bid to fill that gap, UNITAID decided to grant $5 million to the London School of Hygiene and Tropical Medicine to create a harmonized regulatory framework for diagnostics in Africa,” The Guardian writes, describing the development of the Pan-African Harmonisation Working Party (PAHWP) (Filou, 8/6).

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