CLN - Regulatory Roundup

WHO Grants Prequalification to Hologic’s HIV-1 Test

Regulatory Roundup: March 2018

Hologic’s CE-marked Aptima HIV-1 Quant Dx assay has been awarded the World Health Organi-zation prequalification for in vitro diagnostics, which allows global health organizations to consider this test for public sector procurement in resource-limited countries. This assay is the first HIV-1 viral load assay intended for both HIV diagnosis and treatment monitoring, and it detects and quantitates RNA from a broad set of HIV-1 groups and subtypes. The Aptima HIV-1 Quant Dx uses Hologic’s proprietary real-time
-transcription-mediated- amplification technology, a dual target approach against highly conserved regions in the HIV-1 genome, and redundancy of oligonucleotides in order to protect against potential future mutations in the HIV-1 genome. In addition, the test runs on Hologic’s Panther system, a fully automated platform designed to reduce hands-on time for laboratories by providing random and continuous access with rapid turnaround time.