Hologic gains FDA nod for HIV test

November 24, 2020 By Sean Whooley

Hologic (NSDQ:HOLX) announced that it received FDA approval for a diagnostic claim for its HIV-1 viral load monitoring assay.

Marlborough, Mass.-based Hologic’s Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the U.S., according to a news release.

Initially approved in 2016 for viral load monitoring, the Aptima HIV-1 Quant Dx assay runs on Hologic’s fully automated Panther system, which has also been used in recent months for the company’s COVID-19 assays.

The assay uses a dual-target approach against highly conserved regions in the HIV genome to deliver qualitative and quantitative results across HIV-1 groups and subtypes. The assay is also approved for diagnostic and viral load monitoring claims in Europe through the CE Mark.

“This is an exciting new claim for our highly sensitive and reliable HIV test because it has the potential to improve patient care,” Hologic president of diagnostic solutions Kevin Thornal said in the release. “A simultaneous viral load measurement with diagnosis will allow healthcare providers to guide treatment choices for patients to begin therapy immediately. The dual claim will also benefit our clinical laboratory customers, who continuously seek to consolidate their testing as much as possible onto one automated platform.”

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