NEW YORK (GenomeWeb) – Hologic said today that the World Health Organization has granted prequalification status for its CE-marked Aptima HIV-1 Quant Dx, the first HIV-1 viral load assay with a dual claim for both diagnosis and treatment monitoring.
Prequalification status means that the assay meets the WHO's standards of quality, safety, performance, and reliability, and other global health organizations can consider it for public-sector procurement in resource-limited countries.
Employing real-time transcription-mediated amplification technology, the assay runs on Hologic's Panther system, an integrated platform that fully automates testing from sample to result. The system "substantially reduces" hands-on time for laboratories by providing random and continuous access with rapid turnaround time, Hologic said.
Hologic noted that its assay uses a dual-target approach against highly conserved regions in the HIV-1 genome, a sophisticated primer design, and redundancy of oligonucleotides for protection against mutations, helping ensure accurate detection and quantitation of HIV-1. The assay is designed to deliver both sensitivity and precision across a broad set of HIV-1 groups and subtypes, the firm added.
Tom West, president of the diagnostic solutions division at Hologic, said in a statement, "Access to advanced HIV testing platforms is crucial to managing care and mitigating the spread of the disease in low- and middle- income countries."
Globally, about 36.7 million people live with HIV. The largest number of infected people, 19.4 million, live in East and Southern Africa, and 64 percent of all new HIV infections arise in Sub-Saharan Africa, Hologic said.
In a separate announcement today, the firm said that it has launched a private offering of $1 billion in 4.375 percent senior notes due in 2025, as well as new senior notes due in 2028, pursuant to a new indenture that will be executed at closing of the offering.
The 2025 notes and the new 2028 notes will be unsecured obligations of Hologic and guaranteed by certain subsidiaries. The firm said that it intends to use the proceeds of the offering and available cash, including funds from a secured revolving credit facility, to redeem $1.0 billion in outstanding 5.25 percent senior notes due in 2022.