BIONEER CORPORATION

Bioneer Achieves CE IVDR Certification for four World-Class Real-Time PCR Devices

- Cutting-Edge Nanomaterial PCR Block Technology Delivers the fastest PCR Test Results

Bioneer, Inc. announced on the July 16th that it has received CE IVDR certification for 4 world-class real-time PCR devices. These devices significantly reduce testing time and power consumption in various genetic tests and analysis, including molecular diagnostics. The certified models are ExiCycler™ V5 96, 96 Fast, 384, and 384 Fast, capable of testing up to 96 or 384 samples simultaneously. These devices can detect six fluorescences at the same time, allowing multiplex detection of six target pathogens or genes per PCR reaction tube.

The ExiCycler™ V5 is versatile and can be used in a wide range of fields, including pathogen detection and quantification, genetic mutation testing, mRNA and microRNA(miRNA) expression analysis, GMO(genetically modified organism) quantification and qualitative testing, and new drug candidate screening. The ExiCycler™ V5 96 Fast, using industry-standard 0.2㎖ reaction tubes, is the world's most rapid real-time PCR device, achieving a heating rate of 10℃ per second. This was made possible by applying patented nanomaterial technology to the thermal cycler block, drastically reducing the test time to approximately 40 minutes and cutting power consumption by 25%.

During the pandemic, the global demand for real-time PCR devices surged, and the need to shorten PCR test times has continued to grow. In response, Bioneer developed a new material PCR block using its patented copper nanowire, replacing the conventional aluminum PCR reaction block. The company has filed patents in major countries worldwide and prepared a next-generation PCR device business plan. The European CE IVDR (In Vitro Diagnostic Medical Device Regulation), which came into force in 2022, ensures the safety and quality of in vitro diagnostic medical devices.This regulation demands more stringent clinical evidence and enhanced post-market surveillance compared to the previous CE IVDD.

Real-time PCR devices are increasingly used not only in molecular diagnostics but also in animal diagnostics, agriculture, and food testing to accurately detect and quantify DNA/RNA. With the rising demand for advanced technology, the ExiCycler™ V5 96 Fast and ExiCycler™ V5 384 Fast models, featuring nanoblock patented technology, significantly reduce testing time, enable effective testing, and contribute to reducing electricity usage and carbon emissions.

By widely distributing these next-generation PCR devices that can reduce carbon emissions, Bioneer aims to reduce the carbon footprint of laboratories and contribute to the establishment of global ESG standards. Over its 30-year history of dedicated research and development, Bioneer has built an integrated total solution system based on DNA/RNA gene synthesis technology, enabling performance of all processes on new drug development from nucleic acid extraction to candidate substance discovery.