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Bioneer HIV-1 Dx Kit Gets Korea FDA Approval

NEW YORK (GenomeWeb) – Bioneer has received approval from the Ministry of Food and Drug Safety, a division of the Korea Food and Drug Administration, for a diagnostic kit to detect HIV-1.

The kit, called AccuPower HIV-1 Quantitative RT-PCR Kit, quantifies HIV-1 viral RNA from blood samples using Bioneer's semi-automated real-time qPCR molecular diagnostic system, ExiStation.

The kit and instrument have also recently passed a regulatory review and been registered on the purchase list of HIV diagnostic tests by the international non-profit financing organization The Global Fund.

The ExiStation instrument became eligible for procurement by the World Health Organization along with a Zika virus detection kit in 2016, and the HIV-1 kit was CE marked late last year. The company said in a statement that it has also submitted the HIV-1 kit for WHO Prequalification.

Bioneer plans to ultimately market the HIV-1 test to other countries in Southeast Asia, such as Vietnam, Thailand, and Indonesia.

The company noted that the size of the global HIV testing market is predicted to expand from $2.35 billion in 2016 to $3.88 billion in 2021. There are 12,320 HIV patients in Korea, the firm said.