NEW YORK – Bioneer announced Friday that it has received prequalification certification from the World Health Organization for its Bioneer AccuPower HIV-1 Quantitative RT-PCR Kit.
The South Korea-based firm noted that it is the first diagnostics developer in Asia to obtain WHO PQ for such an HIV test and now plans to expand further into global markets.
Certification under the WHO PQ program involves rigorous safety and effectiveness testing as well as verification of manufacturing practices to ensure safe diagnostic and therapeutic products are available in countries lacking stringent regulatory processes. The WHO PQ is often required for procurement by government programs funded through global nonprofit organizations.
The Bioneer AccuPower HIV test runs on the firm's ExiStation V4 test system. The kit can be used to assess viral load of HIV-1 infections, while the instrument automates molecular diagnostic testing. It has previously been approved by regulatory agencies in South Korea, Thailand, Vietnam, Europe, South America, Africa, and Central Asia, Bioneer said.