FDA Expands Approval for Hologic’s HIV Diagnostic
The FDA has granted Hologic an expanded approval for its Aptima HIV-1 Quant Dx assay, allowing the test to be used for diagnosing HIV infection.
The test, which was first approved by the agency in late 2016 for viral-load monitoring, runs on Hologic’s automated Panther system. It is now able to provide a viral-load measurement and diagnosis at the same time.
“A simultaneous viral load measurement with diagnosis will allow healthcare providers to guide treatment choices for patients to begin therapy immediately,” said Kevin Thornal, Hologic’s president of diagnostic solutions. “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.”