Press Releases
Bioneer Becomes First in Asia to Obtain WHO PQ Certification for HIV-1 Quantitative RT-PCR Kit
관리자 / 2024-09-20
Bioneer Becomes First in Asia to
Obtain WHO PQ Certification for HIV-1 Quantitative RT-PCR Kit
Innovative HIV-1 Quantitative Diagnosis
Using Automated ExiStation™ V4 System
Expanding into Undeveloped Countries and Global Markets through WHO PQ
Certification
Bioneer,Inc. announced on September 13th that
its HIV (Human Immunodeficiency Virus) diagnostic kit, the AccuPower® HIV-1
Quantitative RT-PCR Kit (Cat. No: HIV-1111), has successfully completed the
World Health Organization (WHO) Pre-Qualification (PQ) process. This
quantitative molecular diagnostic kit is used for monitoring AIDS patients and
is characterized by its ability to accurately measure the viral load in
infected individuals. With this certification, Bioneer has become the first in
Asia to receive WHO PQ certification for HIV, significantly enhancing its
competitiveness in the global market.
The WHO PQ program, led by the
World Health Organization, is a global certification system that ensures the
safety, effectiveness, and quality of medicines and diagnostic kits for
developing countries. Products are rigorously assessed for international standards,
safety, effectiveness, and compliance with GMP (Good Manufacturing Practices).
Through this PQ certification, Bioneer has gained the qualification to supply
its HIV diagnostic kit to various countries, including developing nations.
The AccuPower® HIV-1 Quantitative
RT-PCR Kit is designed to detect HIV-1 viral load with precision and speed,
making it highly effective for monitoring the progression of the disease. It
operates using Bioneer's automated molecular diagnostic device, the ExiStation™
V4, which optimizes automation and convenience throughout the diagnostic
process. The product has already been approved in several countries, including
South Korea, Thailand, Vietnam, as well as in Europe, South America, Africa,
and Central Asia. The recent WHO PQ certification is expected to further
strengthen its position in the global market.
HIV, if left untreated, gradually
weakens the immune system, leaving infected individuals vulnerable to a wide
range of infections and diseases. Although a cure remains elusive, early
diagnosis and ongoing treatment allow HIV-positive individuals to maintain a
life expectancy and quality of life close to that of uninfected individuals.
According to market research firm Coherent Market Insights, the global HIV
diagnostic market is projected to grow from $4.44 billion USD (approximately
KRW 5.9 trillion) in 2024 at a compound annual growth rate of 9.2%, reaching
$8.24 billion USD (approximately KRW 10.8 trillion) by 2031.
The ExiStation™ system is not only
used for HIV-1 diagnosis but also for a variety of infectious disease
diagnostics, known for its quick and accurate testing capabilities. With this
WHO PQ certification, it is expected to gain increased attention from the
international community and be widely used in numerous clinical trials and
public health projects.
Through this certification, Bioneer
aims to achieve success in the public procurement markets of developing
countries, where HIV diagnosis is critical, as well as expand its market share
in regions such as Africa and South America. The company hopes to contribute to
the early diagnosis, treatment, and prevention of the spread of HIV, further
enhancing its influence in the global public health sector.
A company representative stated,
“This WHO PQ certification marks a significant milestone for the global market
entry of our HIV-1 diagnostic solution. We will continue to introduce
innovative products that contribute to improving global public health in the
future.” ###