Asia Breaks Ground: Bioneer Secures Prestigious WHO PQ Certification for Revolutionary HIV-1 Quantitative RT-PCR Kit
Expanding Access to Underdeveloped Countries and Global Markets
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[Photo provided by Bioneer]
Bioneer has announced the completion of the World Health Organization (WHO) prequalification (PQ) of its HIV (human immunodeficiency virus) diagnostic kit, AccuPower HIV-1 Quantitative RT-PCR Kit (Cat.no: HIV-1111). This kit is a quantitative molecular diagnostic kit used to monitor AIDS patients and is characterized by its ability to accurately measure the level of the virus in an infected person.
The WHO-PQ certification is a global certification system that verifies the standards of manufacturing and quality control through rigorous standards. This certification enables Bioneer to supply the kit on a large scale to many countries, including underdeveloped and developing countries.
AccuPower HIV-1 Quantitative RT-PCR Kit is a product that quantitatively detects HIV-1 virus, enabling precise and rapid monitoring. Bioneer’s automated molecular diagnostic equipment, ExiStation V4, was used to maximize the automation and convenience of the diagnostic process.
HIV (Human Immunodeficiency Virus) is a serious disease that, if left untreated, gradually damages the immune system, making the infected person vulnerable to various infections and diseases. Although there is no cure, early diagnosis and continuous treatment can help HIV-positive people maintain a close to normal life expectancy and quality of life.
The global HIV diagnostics market is expected to grow at an average annual growth rate of 9.2% from USD 4.44 billion (approximately KRW 5.9 trillion) by 2024, reaching USD 8.24 billion (approximately KRW 10.8 trillion) by 2031.
ExiStation is an automated system used not only for the diagnosis of HIV-1 but also for the diagnosis of various infectious diseases and is characterized by rapid and accurate testing. This WHO PQ certification is expected to receive more attention from the international community and be actively used in many clinical research and public health settings.
Through this certification, Bioneer aims to expand its market share in developing countries such as Africa and South America, contributing to the early diagnosis and treatment of HIV-infected people and preventing its spread.