FDA Approves Breakthrough 2-In-1 HIV Test

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There’s been an exciting development in the fight against HIV.

According to Fierce Biotech, a company called Hologic has received approval from the Food and Drug Administration on their HIV test. Health experts are interested in this approval because the company’s test, called the Aptima HIV-1 Quant Dx assay, is the first dual-claim test of its type. The test combines finding out if someone is positive with measuring their viral load. If health experts can know the viral load, the amount of the virus in the body, earlier, they can sooner determine the best treatment for patients.

“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 Hologic’s diagnostic solutions division, in a press release. “A simultaneous viral load measurement with diagnosis will allow healthcare providers to guide treatment choices” and begin treatment immediately.

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“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,” Thornal added.

The FDA had already approved the Aptima HIV-1 for viral load monitoring in 2016. But Hologic wasn’t satisfied with just that. The company pressed further to have the test approved for HIV diagnosis as well. The tests also run on an automated system called Panther. And with more than 2,250 Panther systems already installed in clinical diagnostic laboratories all over the world, this new approval from the FDA can quickly get started on helping people.

Hologic estimates that around 1.2 million people in the U.S. are living with HIV, and about 38,000 new infections were diagnosed in 2018. Now, health experts can help these people and more with a little more speed.


Source: Fierce Biotech, Business Wire,

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