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Hologic Receives Additional FDA Approval for Diagnostic Use of HIV-1 Viral Load Test

NEW YORK ─ The US Food and Drug Administration has approved a diagnostic claim for Hologic's HIV-1 viral load monitoring test, the Aptima HIV-1 Quant Dx assay, making it the first dual-claim assay for both diagnosis and viral load monitoring in the US, the firm announced Friday.

The molecular diagnostic test, which runs on Hologic's fully automated, sample-to-result Panther system, utilizes a dual-target approach against highly conserved regions in the HIV genome, the company said. The test is designed to deliver qualitative and quantitative results across HIV-1 groups and subtypes, Marlborough, Massachusetts-based Hologic added.

"A simultaneous viral load measurement with diagnosis will allow healthcare providers to guide treatment choices for patients to begin therapy immediately," Kevin Thornal, president of diagnostic solutions at Hologic, said in a statement. "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."

Starting treatment at the time of diagnosis is expected to reduce the risk of HIV transmission to others and to maximize prospects for long-term good health, Hologic noted.

The FDA approved the Aptima HIV-1 Quant Dx assay in late 2016 for viral load monitoring.

In 2019, Hologic received CE marking for the Aptima HIV-1 Quant Dx assay that included diagnostic and viral-load monitoring claims.