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.”