The Food and Drug Administration (FDA) approved Hologic’s Aptima test to be used simultaneously to diagnose HIV and to measure viral load. According to the company’s press release, the Aptima HIV-1 Quant Dx Assay is the “first FDA-approved assay for both qualitative diagnosis and quantitative viral load monitoring.”
Offering both tests simultaneously will help health care workers better tailor HIV treatment to their clients—and to do so much faster. This means people who test HIV positive can start proper treatment sooner, improving their prospects for good health.
“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, in the press statement. “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 Aptima test received FDA approval in 2016 for viral load testing. The new approval is for its capability to diagnose HIV.
Based in Marlborough, Massachusetts, Hologic focuses mostly on improving women’s health through the use of medical technology for the early detection and treatment of illness. For more, visit Hologic.com.
In related news, see “Canada OKs At-Home HIV Self-Tests” and “FDA Authorizes First COVID-19 Test for Self-Testing at Home.”