January 23, 2018
1 min read

WHO prequalifies assay for HIV diagnosis, treatment monitoring

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Photo of Tom West
Tom West

Hologic Inc. recently announced that WHO has prequalified the company’s Aptima HIV-1 Quant Dx assay — the first viral load assay with a dual claim for HIV diagnosis and treatment monitoring, according to a press release.

The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test that runs on Hologic’s Panther system, which Tom West, president of the Diagnostic Solutions Division at Hologic, Inc., described as an “integrated platform that fully automates all aspects of testing, from sample to result.”

“The system substantially reduces hands-on time for laboratories by providing random and continuous access with rapid turnaround time,” he told Infectious Disease News. “Time to result is less than 3 hours, making a same-day result possible.”

WHO’s prequalification will allow global health organizations to consider Aptima HIV-1 Quant Dx assay for public procurement in resource-limited countries, according to the release.

“With 64% of all new HIV infection rates coming from sub-Saharan Africa, it is imperative we focus on delivering advanced HIV testing platforms to patients in these resource-limited countries,” West said. “This prequalification further demonstrates Hologic’s commitment to increasing access to this innovative test for patients in need so that we can help reduce the global burden of this deadly disease.” – by Stephanie Viguers

Disclosure: West is an employee of Hologic Inc.