Aptima® HIV-1 Quant Dx Assay Awarded World Health Organization Prequalification

Hologic, Inc. announced today that its CE-marked Aptima^®HIV-1 Quant Dx assay has been awarded World Health Organization (WHO) prequalification for in vitro diagnostics.

The Aptima HIV-1 Quant Dx assay, employing Hologic's proprietary real-time transcription-mediated amplification (TMA) technology, is the first HIV-1 viral load assay with a dual claim for both diagnosis and treatment monitoring. The assay runs on Hologic's Panther^® system, a market-leading, integrated platform that fully automates testing, from sample to result. The system substantially reduces hands-on time for laboratories by providing random and continuous access with rapid turnaround time.

The WHO prequalification means that the Aptima HIV-1 Quant Dx assay meets WHO standards of quality, safety, performance and reliability, and allows global health organizations to consider the Aptima HIV-1 Quant Dx assay for public sector procurement in resource-limited countries.

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"This milestone highlights Hologic's commitment to, and progress toward, advancing the fight against HIV in highly affected regions of the world," said Tom West, President, Diagnostic Solutions Division at Hologic. "Access to advanced HIV testing platforms is crucial to managing care and mitigating the spread of the disease in low- and middle- income countries."

There are 36.7 million people living with HIV globally, with East and Southern Africa bearing the largest number of infected individuals - 19.4 million. Sub-Saharan Africa accounts for 64% of all new HIV infections.

"Hologic has an impressive legacy in the virology space that started two decades ago with the development of nucleic acid tests to screen the blood supply, and qualitative assays for HIV and HCV in the early 2000's," said West. "We leveraged this expertise to develop an innovative and fully automated HIV viral load assay on our Panther instrument that is well suited for laboratories in resource-limited settings. Hologic looks forward to joining the battle to reduce the burden of this global epidemic. "

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