Bioneer said its human immunodeficiency virus type 1 (HIV-1) diagnostic kit has been registered on the purchase list of the Global Fund, an international non-profit financing organization that fights against AIDS, tuberculosis, and malaria.
The biotech firm also won approval for the kit from the Ministry of Food and Drug Safety.
The company has obtained local approval for “AccuPower® HIV-1 Quantitative RT-PCR Kit,” an in vitro diagnostic kit designed for the quantification of HIV-1 in human samples, as of Jan. 29. Two days later, the product made it on the list of the Global Fund’s purchase list, along with molecular diagnostic system “ExiStation.”
In October last year, Bioneer’s HIV-1 diagnostic kit won the European certification as an in-vitro diagnostic kit. The company has also applied for the World Health Organization’s Prequalification.
The company said it is also seeking to release the product in Southeast Asian countries including Vietnam, Thailand, and Indonesia. “We have opened up a path for AIDS patients around the world to use molecular diagnostic products,” Bioneer said.
As a non-profit group fighting AIDS, TB, and malaria, the Global Fund is one of the financing organizations to eradicate AIDS. Registering on the purchase list of the Global Fund is allowed only for products that pass the regulatory review by the specialized committee.
The global HIV diagnostics market is expected to grow at an annual rate of 10.5 percent on average from 2016 to 2021, analysts said.
The size of the 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. In 2017 alone, the nation added 1,191 new HIV patients.