Assay receives additional FDA approval for use as an aid in the diagnosis of HIV infection

Nov. 24, 2020

Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a diagnostic claim for its HIV-1 (human immunodeficiency virus type 1) viral load monitoring assay. The Aptima HIV-1 Quant Dx assay is first dual-claim assay for both diagnosis and viral load monitoring in the United States, according to the company. 

The AptimaHIV-1 Quant Dx assay, which was approved in late 2016 for viral load monitoring, is a molecular diagnostic test that runs on the fully automated, sample-to-result Panther system. The assay utilizes a dual target approach against highly conserved regions in the HIV genome that is designed to deliver reliable, consistent qualitative and quantitative results across HIV-1 groups and subtypes. The Aptima HIV-1 Quant Dx assay also is CE IVD-marked for both diagnostic and viral load monitoring claims. 

“This is an exciting new claim for our highly sensitive and reliable HIV test because it has the potential to improve patient care,” said Kevin Thornal, president of Diagnostic Solutions at Hologic. “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.” 

Starting treatment at the time of diagnosis is expected to reduce the risk of HIV transmission to others and to maximize prospects for long-term good health. There are approximately 1.2 million people living in the US with HIV, with 38,000 new infections in 2018. 

Hologic, Inc. has the release

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