The Aptima HIV-1 Quant Dx assay, already approved for viral load monitoring, has now received Food and Drug Administration approval for initial HIV diagnosis, making it the first product OK’d for both purposes.
The Aptima HIV-1 was approved for viral load monitoring in 2016, and its manufacturer, Hologic, announced Friday that the FDA had approved it for HIV diagnosis.
“This is an exciting new claim for our highly sensitive and reliable HIV test because it has the potential to improve patient care,” Kevin Thornal, president of diagnostic solutions at Hologic, said in a press release. “A simultaneous viral load measurement with diagnosis will allow health care 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.”
The test runs on an automated system known as Panther. More than 2,250 Panther systems have been installed in clinical diagnostic laboratories around the world.
Beginning treatment soon after diagnosis is key to maintaining the health of people living with HIV and helping them to get their viral load to an undetectable level so that the virus cannot be transmitted to others. Being able to diagnose HIV and detect viral load at the same time will help doctors make decisions on treatment more quickly. Without a product like Aptima HIV-1 to do both, a positive HIV diagnosis requires several consecutive tests and in-clinic visits that can take weeks before treatment can begin.