[Daejeon, Republic of Korea - February 8, 2019] Bioneer announced that it has become the first South Korean company to register the HIV-1 Quantitative RT-PCR Kit in the Global Fund purchase list. Furthermore, it obtains the approval of the Korea Food and Drug Administration (KFDA).
On January 29, Bioneer received the KFDA approval for its AccuPower® HIV-1 Quantitative RT-PCR Kit (HIV-1 Kit). Also, on January 31 Bioneer’s HIV-1 Kit and its molecular diagnostic system ExiStation™ were registered on the Global Fund purchase list together.
The global HIV diagnostics market is expected to grow at an average annual rate of 10.5% from 2016 to 2021, with the market expanding from $23.5 billion in 2016 to $38 billion in 2021. According to the KCDC (Center for Disease Control & Prevention, Korea), the number of AIDS patients in Korea was 12,320, with 1,191 new patients reported in 2017 alone.
Bioneer's HIV-1 Kit received the CE-IVD, List A (European In-Vitro Diagnostics Certification) in October last year, and currently is in the process for WHO PQ (Prequalification) application, whilst participating in the public bidding of the other international aid agencies. In addition, with the KFDA approval, Bioneer is negotiating to provide its technology not only in Korea but also in Southeast Asia, including Vietnam, Thailand, and Indonesia in the first half of this year. The HIV testing market in Southeast Asia is estimated at $ 300 million in 2019.
Bioneer official said that "molecular diagnostic products developed and produced from raw materials to equipment by using its patented technology are well recognized overseas". It was further added that "Bioneer products in terms of quality and price are competitive with other similar products of global companies in both local and international markets.”
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About The Global Fund fights AIDS, Tuberculosis and Malaria
A form of a public-private partnership with joint donors and beneficiaries from governments, international organizations, NGOs and the private sector.
Funding for the eradication of AIDS, tuberculosis, and malaria, which is a poverty-causing disease in developing countries. Since its establishment in 2002, nearly $39 billion has been spent on three major disease-related programs in more than 150 countries.
About WHO Recommendations for the Treatment of AIDS
In order to check the progress after treatment with HIV antiviral agents, patients with AIDS need to check the amount of HIV-1 virus in the blood at least twice a year by HIV-1 virus quantitative testing using real-time PCR technology.