Bioneer’s HIV Diagnostic Kit Receives WHO Pre-Qualification Certification

Bioneer’s HIV (Human Immunodeficiency Virus) diagnostic kit, AccuPower HIV-1 Quantitative RT-PCR Kit, has been evaluated by the World Health Organization (WHO) for pre-qualification (PQ) and has successfully completed the process.

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. Bioneer was the first in Asia to obtain the HIV WHO PQ certification, significantly strengthening its competitiveness in the global market.

The WHO-PQ certification system verifies management standards through rigorous standards, ensuring that medicines and diagnostic kits are safe and effective for use in developing countries. This certification enables Bioneer to provide the kit on a large scale to many countries, including underdeveloped and developing countries.

AccuPower HIV-1 Quantitative RT-PCR Kit

AccuPower HIV-1 Quantitative RT-PCR Kit is a product that quantitatively detects HIV-1 virus, enabling precise and rapid monitoring. The kit is used in conjunction with Bioneer’s automated molecular diagnostic equipment, ExiStation V4, to maximize automation and convenience in the diagnostic process.

The kit has already been approved in several countries, including Korea, Thailand, Vietnam, and countries in Europe, South America, Africa, and Central Asia. With the WHO PQ certification, the kit is expected to further expand its presence in the global market.

HIV Diagnostics Market

HIV 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 individuals maintain a near-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 to USD 8.24 billion by 2031. This growth is driven by the increasing need for early diagnosis and treatment of HIV-infected individuals.

ExiStation Automated System

ExiStation is an automated system used for the diagnosis of various infectious diseases, including HIV-1. The system is characterized by rapid and accurate testing, making it an essential tool in clinical research and public health settings.

With the WHO PQ certification, ExiStation is expected to receive more attention from the international community and be actively used in many clinical research and public health settings.

Bioneer’s Commitment to Global Public Health

Bioneer aims to expand its market share in developing countries, particularly in Africa and South America, where HIV diagnosis is crucial. The company is committed to contributing to the early diagnosis and treatment of HIV-infected individuals and preventing the spread of the disease.

A company official stated, “This WHO PQ certification is an important milestone in the advancement of HIV-1 diagnostic solutions in the global market. We will continue to introduce innovative products that can help improve global public health.”