Press Release

> Development of iron-qPCR in low- and middle-income countries via FIND (global non-profit organization expanding access and supply of rapid diagnostic products) 

> BIONEER to expand into molecular diagnostics market with a multiplex respiratory panel developed with FIND

BIONEER received an investment from FIND, the global alliance for diagnostics, a global non-profit seeking to ensure equitable access to reliable diagnosis around the world by working with partners to spur diagnostic innovation and make testing an integral part of sustainable, resilient health systems.  

BIONEER announced on XX that it signed a POC(Point-of-Care) Molecular Diagnostics product development agreement with FIND. Under the agreement, BIONEER will provide POC molecular diagnostics equipment Iron-qPCR, and related kits to low- and middle-income countries. 

According to the agreement, BIONEER receives funding worth US$6 million from KfW(Kreditanstalt fuer Wiederaufbau), to enable the development of a COVID-19/Flu/RSV assay, the clinical validation in LMICs, and production of the assay and instruments. The funding will be spread over 4 instalments. With the financial support, FIND also commits to procedural support, such as independent with clinical evaluations that will provide data for the regulatory submissions that are required for the sales of Iron-qPCR equipment and related kits in low- and middle-income countries.

As the reason for selecting BIONEER among numerous molecular diagnostics companies worldwide, FIND mentioned Iron-qPCR’s high multiplexing capacity, Bioneer’s commitment to pricing in LMICs, and Bioneer’s manufacturing capacity. Last month, BIONEER opened the Global Center in Techno Valley (Yuseong-gu, Korea), expanding its Nucleic Acid Extraction kit production capacity up to 930 billion Won at full capacity. 

FIND also emphasized Iron-qPCR has the potential to detect other important pathogens like TB and pathogens associated with AMR.

Iron-qPCR also shows advantages over other equipment in terms of testing time. It takes up to 30 minutes to get results, which is almost one-fourth shorter than that of existing equipment and kits (120-150 minutes). 

BIONEER sees the development agreement with FIND as the starting point to establish its position in the next-generation molecular diagnostics market. As part of its remit, FIND conducts independent evaluations of new diagnostic technologies, generating data that can be shared with WHO and other decision-makers, including ministries of health, as well as international organizations.  Through a development partnership with FIND, Bioneer has the potential to access the large public and private sector market for molecular diagnostics in LMICs.  .

Additionally, BIONEER signed a contract last year with the Iraq Ministry of Health, supplying all equipment and kits needed to construct a turnkey laboratory. The Iraq Ministry of Health selected BIONEER as a partner for the laboratory construction over the leading global companies.

BIONEER will form a steering committee with FIND to develop strategies to launch and support sales of Iron qPCR in LMICs.  

"BIONEER fully prepared for the large scale production with the Global Center opened up last month. We see this as a great opportunity to move forward with deals on the national level," said Han-oh Park, CEO of BIONEER. He added, "BIONEER will corner the global molecular diagnostics market with Iron-qPCR at the forefront".


On December 17, BIONEER(064550) announced that it developed a diagnostics test that can detect Omicron alone and a test that can distinguish between Omicron and Delta variants.

BIONEER is the first company in Korea to develop two tests at once. The development of these tests is an achievement of cooperation with the Korea Centers for Disease Control and Prevention. BIONEER expects the two tests to fulfill emergency demands as various governments are announcing quarantine policies to block the Omicron variant that is rapidly spreading.

BIONEER explained the background to develop the test that distinguishes between Omicron and Delta variants, which is related to the severeness of symptoms. As Omicron patients show "fairly mild" symptoms, Delta patients face a risk of "severe" symptoms. Thus, patients can get appropriate and prompt treatments if the variants are distinguished.

BIONEER has already developed and launched the COVID-19 variant diagnostics tests for the alpha, delta, delta+ variants, in both domestic and international markets. It is the only biotechnology company in Korea to provide comprehensive solutions to molecular diagnostics, producing from raw materials, equipment, to reagents with its all in-house manufacturing system. Its all-in-house manufacturing system allows relatively quicker development and release of new products.

BIONEER conducts a genetic analysis of virus variants every month. It designed an Oligo set that can specifically detect Omicron variant, by analyzing the Omicron variant genes. BIONEER says it can sufficiently handle the cases of new variants with its synthetic biology technology that utilizes genetic analysis, big data, and AI(Artificial Intelligence).

"BIONEER's technology accumulated for last 30 years, the efforts of our researchers, and the cooperation with the Korea Centers for Disease Control and Prevention led us to develop both diagnostics kits in a short time. We hope our new products to contribute to the quarantine in and out of Korea," said Nam-il Kim, head of the Diagnostic Reagent Division.


On February 25, 2021, BIONEER Corporation announced the launching of a new concept auxiliary device, “AccuLoader™,” designed to assist with the dispensation of samples and reagents to the correct wells and reduce the time spent on the sample preparation. 

AccuLoader™ is the world’s first patented precision auxiliary device developed by BIONEER Corporation. It can be applied to various molecular diagnostic tests, including COVID-19 tests. The device has a variety of functions ranging from scanning the information on a sample tube to automatically adjusting the position of the well for correct sample dispensation. It is also equipped with parts that aid in minimizing the chances of cross-contamination. Moreover, its dedicated mobile app, the “AccuLoader,” allows for managing and merging of all sample information collected from the same run.

Molecular diagnosis of COVID-19 is primarily composed of three main steps: sample preparation, nucleic acid extraction, and nucleic acid amplification.

Generally, a molecular diagnostic test begins with the first step of loading the samples into the correct wells with accuracy. These samples, which are collected from the patient, must be loaded into the plate of the nucleic acid extractor. During this process, small, microscopic splashes of samples with the target pathogen could enter the adjacent wells or the samples may get loaded into a wrong well by mistake, possibly resulting in cross-contamination and false-positive errors. Consequently, dealing with a large number of samples would require a great deal of skill and concentration – in other words, the testing personnel experience a long preparation time and fatigue.

AccuLoader™ developed by BIONEER allows users to load the samples into the correct wells and blocks the splashes from entering the well, in order to ultimately prevent the obtaining of false-positive or false-negative results caused by cross-contamination or human errors.

In addition, AccuLoader™ demonstrates an excellent performance in the COVID-19 pool test. By using the pooling setting in the mobile app, samples can be quickly loaded into the correct wells irrespective of the user's expertise. All sample data will be automatically organized within the app to help users easily track and manage the pooled sample information.

“In times like today, where it is difficult to foster in a short period of time the experts of molecular diagnostics to accommodate the ever-increasing demand for mass testing for COVID-19, our AccuLoader™ will become an essential device for the molecular diagnostics field,” stated a source from BIONEER Corporation. “We are aiming for more than 5,000 sales to the molecular diagnostic centers worldwide.”

BIONEER Corporation is the only company in the Republic of Korea to offer the “total solution for COVID-19 diagnostic tests.” It has supplied its molecular diagnostic instruments to more than 90 countries, and has provided more than 40 types of kits for nucleic acid extraction and disease diagnosis. In continuation of last year’s escalated revenue, the company is again expecting a high sales growth this year with its large-scale development and supply of the above products.

https://youtu.be/dd7mmFe1JIk


[Daejeon, Republic of Korea – November 18, 2020] On November 11th, Bioneer received CE-IVD marking for its newly launched molecular diagnostic kits, ‘AccuPower® RV1 Real-Time RT-PCR Kit’ and ‘AccuPower® RV1 Multiplex Kit’, that can diagnose both COVID-19 and influenza.

AccuPower® RV1 Real-Time RT-PCR Kit is customized to Bioneer’s automated molecular diagnostic system, and AccuPower® RV1 Multiplex Kit is compatible with other PCR equipment in the market.

The Bioneer’s AccuPower® RV1 kits use a single sample to detect COVD-19 (E gene, RdRp & N gene) and Influenza A/B, resulting in much faster test results than separately testing each sample.

At the early stage, symptoms of COVID-19 and Influenza are very similar yet caused by completely different viruses. Therefore, accurate and timely testing results are important to treat each disease.

There are many reports that COVID-19 viruses are mutating constantly. Although COVID-19 vaccines and treatments are ready to be launched in near future, patients cannot be diagnosed only by their symptoms. It is inevitable that PCR testing is necessary not only to diagnose the patients properly but to minimize any confusion or possible collapse in medical and quarantine systems in many countries around the world.

Bioneer is the only company in South Korea to provide a total solution to the molecular diagnostic system. The company manufactures and supplies nucleic extractor, preparation kit, Real-time PCR equipment, and PCR kits, the four major products that require in molecular testing, to over 80 countries in the world.


Bioneer's Multiplex Assay for Flu and COVID-19



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About the Multiplex Assay for Flu and COVID-19

Bioneer received CE-mark certification for the Multiplex Assay for Flu and COVID-19.

It is an in vitro diagnostic kit that helps diagnose COVID-19 & Influenza infections. The kit is able to detect 5 targets about COVID-19(E gene, RdRp & N gene) and Influenza A/B in a tube.

It leverages the company’s original patented technology Dual-HotStart™. It can detect RNA target from clinical samples with high sensitivity and specificity through eliminating non-specific synthesis and amplification.

 

About BIONEER Corporation

Established in 1992, BIONEER is the first Korean biotechnology company and is publicly traded at KOSDAQ since 2005.

Bioneer has developed state-of-the-art molecular biology products and technologies over the years, including oligonucleotides, thermostable polymerases, and unique dual hot starter PCR system together with DNA/RNA synthesizer, automatic nucleic acid extractor, thermal cycler and real-time PCR instruments. Bioneer’s popular MDx system ExiStation™ offers 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.


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