BIONEER CORPORATION

Bioneer Secures Europe's Top-Grade CE-IVDR Class D Certification for Its HBV and HCV Molecular Diagnostic Kits

- Room-temperature-transportable kits now cover all three major chronic viruses, including HIV—targeting the global procurement market

- Fully automated from tube capping to results—up to 96 samples per run, delivering up to 93 test results within 2 hours

 

Bioneer announced on the 20th that its HBV (hepatitis B virus) and HCV (hepatitis C virus) quantitative diagnostic kits for the fully automated molecular diagnostic system 'ExiStation™ FA 96'—developed with support from KMDF (Korea Medical Device Development Foundation)—have obtained Class D certification, the highest-risk category under the EU In Vitro Diagnostic Regulation (CE-IVDR), following the earlier certification of its HIV-1 kit. Class D is the highest-risk grade under CE-IVDR for infectious-disease diagnostic products. Together with its previously certified HIV-1 product, Bioneer has now completed a quantitative diagnostic lineup covering all three major chronic viral infections—HIV, HBV, and HCV. The company plans to accelerate its entry into the global public-procurement market on the strength of cold-chain-free, room-temperature transport and high-speed, fully automated testing.

 

## Setting Its Sights on the $6.2 Billion Viral Load Testing Market

 

Viral load testing is a high-value diagnostic segment in which tests are performed repeatedly to monitor treatment response, drug resistance, and disease progression. Market researchers estimate the global viral load testing market—covering HIV, hepatitis, and other infections—at about US$6.2 billion in 2025, with HIV making up the largest share at 42.8%.[i] The HCV viral load testing market alone is projected to grow from US$1.48 billion in 2026 to US$1.98 billion in 2030, a compound annual growth rate of 7.4%.[ii]

 

The underlying patient base is large as well. Worldwide, an estimated 240 million people had chronic HBV infection as of 2024, and about 47 million had HCV.[iii] About 40.9 million people were living with HIV as of 2025, of whom 32.1 million were receiving antiretroviral therapy—sustaining steady demand for routine viral load testing to monitor treatment effectiveness.[iv]

 

## Room-Temperature Transport, Enabled by Lyophilized Reagents

 

The leading players in the high-volume, fully automated viral load testing market include Roche, Abbott, and Hologic. These platforms also offer HIV/HBV/HCV quantitative assays and high-throughput capacity, but some require a cold chain for reagent transport and storage. Bioneer, by contrast, has developed its PCR reagents in lyophilized (freeze-dried) form, allowing room-temperature transport without refrigeration or freezing equipment. According to the company, this lowers shipping costs and reliance on electricity, enabling fast, cost-effective supply even to regions with limited cold-chain infrastructure such as Africa, Southeast Asia, and South America.

 

Beyond reagent price alone, the approach lowers the total cost of testing. By cutting the cost of refrigerated transport and storage infrastructure, ongoing power expenses, and the risk of product loss from cold-chain breaks, the system is well suited to large-scale public procurement in low- and middle-income countries (LMICs).

 

 

## Automated from Tube Capping On—Up to 96 Samples per Run, Results Within 2 Hours

 

The 'ExiStation™ FA 96' automates the entire workflow on a single instrument—from automated capping and uncapping of sample tubes to nucleic acid extraction, real-time PCR analysis, and result reporting. Once up to 96 samples are loaded, the system delivers up to 93 test results within 2 hours, with the remaining positions reserved for controls. Because operators no longer open and close HIV, HBV, and HCV sample tubes by hand, the system reduces their exposure to high-risk specimens. Built-in contamination-prevention features also minimize cross-contamination and manual error.

 

Bioneer's edge lies in combining, on a single platform: room-temperature transport of lyophilized reagents; full automation from tube capping through result reporting; and high-speed analysis that processes up to 96 samples per run within 2 hours. The strategy delivers lower logistics costs, greater operator safety, and high-throughput efficiency all at once.

 

## A Two-Track Push: European Hospitals and Global Public Procurement

 

Building on the certification, Bioneer will expand sales to university hospitals and large reference laboratories across Europe. It also plans to pursue WHO Prequalification (WHO PQ) to enter the LMIC public-procurement markets led by bodies such as the Global Fund and PEPFAR (the U.S. President's Emergency Plan for AIDS Relief), aiming to secure large-scale, long-term supply contracts.

 

A Bioneer official said, "The global viral load market has long been led by a handful of multinationals, but cold-chain costs and the burden of handling high-risk specimens remain unsolved challenges," adding, "By combining room-temperature reagents, fully automated tube handling, and the capacity to run up to 96 samples per run—delivering up to 93 test results in 2 hours—Bioneer will offer a supply model unlike the incumbent competitive structure."

 

The official continued, "By pursuing advanced European markets and LMIC public-procurement markets in Africa and elsewhere at the same time, we aim to become a core supplier in the global chronic viral diagnostics market." (End)