Hologic’s HIV-1 Quant Dx assay receives WHO prequalification

Hologic has announced that its Aptima HIV-1 Quant Dx assay has been awarded World Health Organization (WHO) prequalification for in vitro diagnostic use.

The CE Mark-approved assay uses real-time transcription-mediated amplification technology for HIV diagnosis and treatment monitoring, and runs on Hologic's Panther automated testing platform.

WHO prequalification means the Aptima HIV-1 Quant Dx assay has been deemed to meet WHO standards of quality, safety, performance and reliability, allowing global health organisations to consider the option for public sector procurement in resource-limited countries.

It has been designed to substantially reduce hands-on time for laboratories by providing random and continuous access and a rapid turnaround time, all of which are highly important benefits for users in remote regions.

Tom West, president of Hologic's diagnostic solutions division, said: "This milestone highlights Hologic's commitment to, and progress toward, advancing the fight against HIV in highly affected regions of the world."

This builds on Hologic's strong legacy in the virology space, which commenced with the development of nucleic acid tests to screen blood supplies two decades ago. It subsequently created qualitative assays for HIV and hepatitis C in the early 2000s.

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