Bioneer
Leading the Innovation in Molecular Diagnostics

“If you know the enemy and know yourself, you need not fear the result of a hundred battles.” This famous saying from the book—The Art of War—written 2,500 years ago by Chinese General Sun Tzu holds even for the internal enemies of human bodies, i.e., the disease-causing pathogens.

When it comes to proper prognosis of health conditions and guide treatment decisions, a thorough understanding of the disease is of utmost necessity. On that note, in-vitro diagnostic (IVD) solutions have become a critical tool in medical practices and emergencies; and most treatment decisions today are based on IVD results. They facilitate evidence-based medicine to detect diseases, promote wellness, improve patient outcomes, and advance public health. Given this stature of advantages, IVD solutions, thus, are playing a pivotal role in the ongoing battle against the COVID-19 pandemic as well. IVD tests are now being deployed globally to significantly increase the novel coronavirus testing capacity and throughput and protect public health through early detection.

With this pandemic bringing forth unprecedented demand for IVD solutions, certain solution providers are standing out because of their extensive experience in the domain. Bioneer is one such maven in biotechnology that leverages its decades of expertise in molecular diagnostics (MDx) and genetic technologies to help healthcare professionals navigate the complex and interrelated IVD development requirements in a better way.

Founded by Dr. Han-Oh Park in 1992, Bioneer has developed state-of-the-art molecular biology products and technologies over the years, including modified oligonucleotides, thermostable polymerases, and unique dual hot starter PCR system together with DNA/RNA synthesizer, automatic nucleic acid extractor, thermal cycler, real-time PCR instruments and in vitro protein synthesizer. “In the early 2000s, we noticed a paradigm shift in healthcare toward precision medicine with the completion of the human genome project. Hence, we started focusing on the development of the MDx technologies,” says Dr. Park, the president and CEO of Bioneer.

What gives Bioneer an edge over its competitors is its in-house R&D and manufacturing system. Bioneer directs more than 40 percent of its revenue into R&D to continually enhance its capabilities around the integration of recombinant DNA technology, fermentation, biochemistry, and nucleic acid chemistry, in addition to mechanics, photonics and electronics. Through such ambitious investments and its vertically-integrated manufacturing facilities, Bioneer has also successfully commercialized enzymes for PCR, oligos, primers, and real-time PCR instruments. The manufacturing facilities have a capacity of producing nucleic acid extraction and diagnostics kits for more than 5 lakh tests per day. By setting up a mass production system throughout its fully-connected smart factories, Bioneer can synthesize over 30,000 oligonucleotides and manufacture one ton of phosphoramidite, over billion units of the polymerase, and hundreds of kilograms of magnetic silica nano particles per day for nucleic acid purification. Apart from the comprehensive R&D capacities, Bioneer also excels in contemporary solutions to support R&D advancements. Bioneer has created a full line and differentiated MDx systems composed of 96-well/384-well real-timePCR instruments and 16/48/96 automatic extractors with a high throughput of up to 5,000 tests per day.

Bioneer has created a full line and differentiated MDx systems composed of 96-well/384-well real-time PCR instruments and 16/48/96 automatic extractors with a high throughput of up to 5,000 tests per day

Notably, all of its MDx systems are battle-tested and tailor-made to detect complex disease-causing organisms, such as Mers-CoV, Ebola, and ZIKA viruses. For example, Bioneer’s popular MDx system ExiStation™ was developed during the swine-flu pandemic in 2008 to offer an efficient, automated, and pipetting-free system that minimizes hands-on steps from nucleic acid extraction to PCR processes. ExiStation™ is equipped with an aerosol protection system to prevent contamination and secondary infection by users and provides an accurate test result. Similarly, its AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit was the first multiplex in-vitro diagnostic test sanctioned by the World Health Organization (WHO) during the ZIKA virus epidemic in 2016. These kits can detect RNA targets from clinical samples with high sensitivity and specificity by eliminating non-specific synthesis and amplification. In addition to these diseases, Bioneer also contributes to public health by supplying more than 40 kinds of kits for diagnostics of HIV, Hepatitis B, Hepatitis C, sexually-transmitted infections, and Tuberculosis. It is also the first and the only company in Asia to receive CE-IVD, List A certification for HIV-1, HBV, and HCV viral load assays.

Such comprehensive and proven capabilities are now at the core of Bioneer’s phenomenal work during the ongoing COVID-19 pandemic. Bioneer has already extended its expertise to more than 70 countries around the world with its MDx system ExiStation™, and the COVID-19 detection kits:AccuPower® SARS-CoV-2 Multiplex RT-PCR Kit and AccuPower® COVID-19 RT-PCR Kit. The AccuPower® SARS-CoV-2 Multiplex RT-PCR Kit, in particular, helps in the detection of specific genes specific to the COVID-19—E, N, and RdRP genes.

Augmenting these efforts, Bioneer has recently initiated two subsidiaries: AceBiome Inc. and siRNAgen Therapeutics Corp. While AceBiome Inc. specializes in probiotics supplement development for disease prevention, siRNAgen Therapeutics Corp. specializes in developing RNA interference therapeutics for anti-fibrotic, anti-proliferative, anti-cancer, and COVID-19. And through these two subsidiaries, Bioneer plans to develop an innovative diagnostic and therapeutic platform based on genomic technologies to make a healthier future for humanity.

Moving ahead with such pivotal grace, Bioneer is now ramping up its production capacity to meet the increasing customer demands. Besides two production and research facilities in Korea, Bioneer has a distribution facility in the U.S. The company is also pursuing complete automation of hands-on processing. Through these initiatives, Bioneer is currently poised to develop next-generation technologies in the post-genome era through the invention of new biochemistry and instruments. Bioneer is also about to launch a near-patient point-of-care molecular diagnostic platform called IRON-qPCR™, which can test the most infected pathogens and antimicrobial resistance within 30 minutes. “We believe that IRON-qPCR™ will be an essential tool for blocking infectious diseases, such as COVID-19, RSV, Influenza A and B, and TB. It will be a landmark in the progress of precision medicine,” concludes Dr.Park.