Press Releases
Bioneer becomes the first Korean company to register the HIV-1 Kit in the Global Fund purchase list
관리자 / 2022-09-01
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.”
# # #
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.