FDA Approves Assay to Have a Dual Claim for Both HIV Diagnosis and Viral Load Monitoring

The US Food and Drug Administration (FDA) announced yesterday that the Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the United States.

The assay is manufactured by Marlborough, MA-based Hologic, a medical technology company primarily focused on women’s health through early detection and treatment.

“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. “A simultaneous viral load measurement with diagnosis will allow healthcare 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 assay utilizes a dual target approach against highly conserved regions in the HIV genome that is designed to deliver qualitative and quantitative results across HIV-1 groups and subtypes. The Aptima HIV-1 Quant Dx assay is CE IVD-marked for both diagnostic and viral load monitoring claims.