Hologic receives CE Mark for Aptima HIV-1 Quant Dx assay

Hologic has announced that its Aptima HIV-1 Quant Dx assay has been granted European CE Mark approval.

Designed for use on the company's Panther system, the assay employs Hologic's proprietary real-time transcription-mediated amplification technology and represents the company's entry into the viral load market.

It is the first HIV viral load assay with a dual claim for both diagnosis and treatment monitoring. It targets highly conserved regions in the HIV genome and offers a sophisticated primer design, while oligonucleotide redundancy provides protection against mutations, thereby helping to ensure accurate detection.

The product has been designed to deliver both sensitivity and precision across a broad set of HIV-1 groups and subtypes.

Tom West, division president for diagnostic solutions at Hologic, said: "The Aptima HIV-1 Quant Dx assay combines exceptional performance with the Panther system's full automation, and extends our commitment to give customers more freedom and control over workflow in viral load testing."

It follows the introduction of the company's NovaSure 6mm global endometrial ablation system, for the treatment of abnormal uterine bleeding, last month.