FDA approves first combined test for HIV diagnosis and viral load monitoring
Hologic announced that it received an additional FDA approval for its HIV-1 viral load monitoring assay.
The Aptima HIV-1 Quant Dx assay is now also approved for diagnosing HIV — the first dual-claim assay for diagnosis and viral load monitoring in the United States, the company said.
The molecular diagnostic test runs on the fully automated, sample-to-result Panther System and uses a dual-target approach against the HIV genome that is designed to deliver reliable, consistent qualitative and quantitative results across HIV-1 groups, according to Hologic.
The test was approved for viral load monitoring in late 2016.
According to Hologic, using the assay to facilitate treatment at the time of diagnosis is expected to reduce the risk for HIV transmission to others and to “maximize prospects for long-term 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,” Kevin Thornal, president of diagnostic solutions at Hologic, said in the release. “A simultaneous viral load measurement with diagnosis will allow health care providers to guide treatment choices for patients to begin therapy immediately.”
He said 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.”