- Seegene launches new multiplex PCR test capable of screening six SARS-CoV-2 variants including the Delta and Delta Plus variants attributable for a recent surge in global COVID-19 cases. - The new CE-IVD marked variants detection kit to differentiate 10 major COVID-19 variants including the alpha, beta, epsilon as well as delta, when used in conjunction with the company’s first variants detection kit previously launched in March. South Korea’s leading biotechnology firm Seegene Inc. (KQ 096530) has announced the launch of a new SARS-CoV-2 variant diagnostic test capable of screening newly emerging virus variants including the Delta and the Delta Plus that have become the dominant version of the virus circulating around the world. Seegene announced on June 30, that it has received the CE-IVD mark for its ‘Allplex™ SARS-CoV-2 Variants II Assay,’ a new lineup of the company’s variant detection kits capable of detecting the key genetic mutations of SARS-CoV-2 variants such as L452R, W152C, K417T and K417N. In a single reaction, the variants diagnostic kit identifies a total of six COVID-19 variants that are known to be originated from India such as Delta, Delta Plus, and Kappa, and Gamma(Brazil), Beta(South Africa), and Epsilon(California). While the number of daily new infections is growing exponentially, the launch of the new assay is expected to play an essential role in monitoring the spread of the Delta and Delta Plus variants that have been largely blamed for the bulk of new infections. Earlier this year, the World Health Organization (WHO) has classified the Delta variant as the ‘Variant of Concern’ as the variants is expected to rapidly outcompete other variants. Also, the emergence of a new mutation on the spike protein of the Delta known as K417N has raised alarm globally, as it is known to be more contagious than the Delta and exhibit vaccine resistance. These super-contagious variants recently have become a global threat. In countries like the UK and Indonesia Delta is the dominant strain accounting for around 90% of new cases. Also, in other countries like the United States, although the variant only made up about 20% of infections, the number appears to be doubling every two weeks. Under such circumstances, the introduction of the ‘Allplex™ SARS-CoV-2 Variants II Assay’ is receiving much attention from around the world as the assay can screen both Delta and the Delta Plus variant as well as other major COVID-19 variants. Seegene also said that it has successfully developed a research-use-only diagnostic tests, ‘Allplex™ SARS-CoV-2/P681R Assay,’ to precisely target the Delta and Delta Plus variants. According to the company, the conjunction use of the two assays will allow researchers to accurately distinguish the Delta and Delta Plus variants from other genetic mutations. Although many countries are speeding up with the vaccination process, Gavi, the global Vaccine alliance stresses the importance of surveillance screening, saying that the Delta Plus variant was found during routine screening. According to Seegene, the combination use of its two assays including ‘Allplex™ SARS-CoV-2 Variants II Assay’ and the ‘Allplex™ SARS-CoV-2 Variants I Assay’ can screen almost all existing COVID-19 variants. As the two assays can detect multiple variants in a single test, it also streamlines the conventional testing process in which it requires a secondary test to identify new variants. In such context, Seegene’s variant detection kit is expected to become a new ‘gold standard,’ helping to prevent new pandemics from occurring. “An increased transmissibility, short incubation period, and a potential reduction in vaccine efficacy are the characteristics of the Delta and Delta Plus variants,” said Min-cheol Lee, Seegene’s Chief Technology Officer. “I know that there is currently a lot of concern about the Delta variants. While experts and the WHO are largely cautioning the public and governments to remain watchful, I believe that our latest two diagnostic tests will play a key role in the early detection of different viruses and help prevent the further spread of SARS-CoV-2,” he added.
Jul 13, 2021View Detail >
- Seegene announces partnership with Bio-Rad for the development and commercialization of infectious disease molecular diagnostic products - Diagnostic tests designed for the pandemic and the post-pandemic era with high multiplex technology - A significant step forward for Seegene in expanding its business to the U.S., the world’s biggest in vitro diagnostics market. Seegene Inc. (KQ 096530), a South Korean leading biotechnology firm has signed a partnership agreement with American biotechnology company Bio-Rad Laboratories, Inc. to support entering the U.S. market. Seegene announced on July 1 that it has signed a partnership with Bio-Rad, laboratories, Inc. for the clinical development and commercialization of infectious disease molecular diagnostic products. Under the terms of the agreement, Seegene will provide diagnostic tests for use on Bio-Rad’s CFX96™ Dx Real-Time PCR System for the U.S. market, pending clinical development and approval from the U.S. Food & Drug Administration (FDA). According to the ‘Report on the U.S. In Vitro Diagnostics market Trend’ released by the Korea Trade-Investment Promotion Agency (KOTRA) in 2020, North America is a very important market, accounting for about 37 percent of the global in vitro Diagnostic Industry. However, it has been difficult for newer foreign companies to enter the U.S. market because the market has already been dominated by well-established global companies and the U.S. government prioritizes its domestic products. Under such circumstances, the supply deal with Bio-Rad, a biotech giant with over 60 years of history, is expected to be a significant step forward for Seegene in entering the U.S. market. Founded in 1952, Bio-Rad is a global leader in the fields of life science and clinical diagnostics. The company has been Seegene’s major partner over the past ten years. Previously, Seegene was able to generate some 1 trillion won worth of sales revenue by applying its diagnostic assays to Bio-Rad’s PCR systems that had already been installed globally. This new partnership is expected to streamline the process for Seegene to seek U.S. FDA clearance and the partnership of the two world class companies is expected to drive new U.S. market opportunity. Seegene plans to submit applications for FDA approval for its diagnostic reagent made of the firm’s high-multiplex diagnostic technology, which is unique in its capability to simultaneously screen multiple target genes on a high throughput real time PCR system. Using Seegene’s proprietary technologies, it can also selectively amplify target genes while identifying different viruses and the number of viruses. Thanks to the deal, Seegene will partner with Bio-Rad to plan to seek U.S. FDA clearance and offer a wide range of its products to U.S. customers. Under the deal, Seegene intends to seek U.S. FDA clearance for clinical assays on Bio-Rad’s real-time PCR system ‘CFX96 (TM) Dx Real-Time PCR System’. This includes an intent to clear Seegene’s ‘AllplexTM SARS-CoV-2/FluA/FluB/RSV Assay’, a multiplex real-time PCR assay. Going forward, the company says it is also planning to establish research and manufacturing facilities in the United States. This deal provides the potential access for Seegene to enter the US market with items selected among over 150 diagnostic assays already sold globally. The AllplexTM SARS-CoV-2/FluA/FluB/RSV Assay can simultaneously detect and differentiate a total of five viruses including Flu A, Flu B, RSV A/B and three target genes of COVID-19 (N gene, S gene and RdRP gene) in a single test. It is also suitable for mass testing and capable of targeting more genes than its competitors’ products. It is also expected to play a critical role in a new pandemic situation by detecting various respiratory diseases as well as genetic variants which may resurge in the U.S. when the country eases prevention guidelines following the nationwide vaccination. Ho Yi, Chief Sales and Marketing Officer of Seegene said, “To expand our business in the U.S. market, it is important to work closely with a global company like Bio-Rad that has comprehensive network in the region. Together with Seegene’s advanced technology and Bio-Rad’s solid client base, the two will be able to take the lead in the U.S. market.” He added that “The deal is expected to serve as the steppingstone for Seegene to secure its foothold in the U.S.market. And it will also help increase the company’s revenue and expand the business into other countries going forward.”
Jun 30, 2021View Detail >
- Seegene unveils "MOBILE STATION" at the Medlab Middle East 2021 - Mobile laboratory designed for mass testing at schools, airports, or communities, delivering test results within 3h 30min with the maximum testing capacity of 7,500 a day - The biotechnology firm to sign an MOU with G42 Healthcare, a leading health-tech company based in Abu Dhabi, expanding diagnostics business opportunity in the Middle East South Korea's leading biotechnology firm Seegene Inc. (KQ 096530) today introduced its new deployable container laboratory "MOBILE STATION", at the Medlab Middle East 2021, the world's largest medical laboratory and In Vitro Diagnostic exhibition which is taking place in Dubai from June 21 to 24. Seegene's MOBILE STATION, an innovative laboratory-on-wheels facility, is designed to deploy the gold standard PCR testing solution to anywhere community-based testing is needed. While many countries around the world are planning to re-open their borders, schools, and public-use facilities, MOBILE STATION is considered an ideal option for conducting mass PCR testing in such locations. Also, MOBILE STATION can be mobilized anytime, allowing more people to utilize molecular diagnostics when needed. MOBILE STATION sets the new bar of PCR lab setting with its ability to deliver effective testing solutions to anywhere testing is needed. PCR testing has been normally conducted only at fixed space due to concerns of cross-contamination. However, MOBILE STATION, with Seegene's technology and know-how gained through operation of South Korea's largest reference laboratory, has already minimized the overall risks of aerosol contamination posed in PCR process by installing Class 2 (A2) Bio-Safety Cabinet and negative pressure room. From sample collection to automated interpretation of results, it offers streamlined and automated workflow backed by the company's All-in-One platform thereby allowing equitable access to health care for the public. Seegene's All-in-One platform, when fully utilized, can conduct up to 7500 tests per day with a turnaround time of 3.5 hours. Seegene's pioneering concept of the mobile laboratory is expected to play a significant role in stopping the current pandemic since Seegene offers unparalleled PCR testing solution with its exclusive multiplex assays including Allplex™ SARS-CoV-2 Master Assay, a kit that simultaneously detects COVID-19 and multiple virus variants and Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay, a kit differentiates 8 target genes including Flu A, Flu B, RSV A/B and three different target genes of COVID-19. MOBILE STATION is also fully compatible with Seegene's more than 150 multiplex assay menus including tests for respiratory infectious pathogens, HPV, STI, and GI. Seegene also introduced 'Combo Swab', a self-administrable sample collection device. In comparison to nasopharyngeal swab, typically used in sampling for COVID-19 PCR testing, in which health care providers collect samples by inserting a swab deep inside nostrils, Combo Swab allows individuals to simply collect samples with two individual swabs through swirling around their nasal and oral cavity by two individual swabs without any discomfort. In addition, Combo Swab with dual sample collection showed the same accuracy compared to nasopharyngeal swab. Self-sample collection availability of Combo Swab along with provisional space scalability of MOBILE STATION enables mass testing to be proceed in a quicker time and more efficient manner than the conventional process. Meanwhile, 'Seegene Middle East,' the company's Middle East subsidiary, signed an MOU on the same day, with Group 42 healthcare, a leading Information Technology and healthcare company to promote the MOBILE STATION in the Middle East and North Africa. Min-cheol Lee, Seegene's Chief Technology Officer said, "As COVID-19 is likely to become endemic, the MOBILE STATION will play a key role in not only detecting COVID-19, but also closely monitoring other new viruses that can threaten our daily lives in the future. Seegene's multiple virus variant detection kits can detect the new strains of virus and prevent them from turning into an additional outbreak of subsequent pandemic waves.
Jun 29, 2021View Detail >
Seegene Inc. (KQ 096530), a biotechnology firm specializing in molecular diagnostics has once again been recognized for its unique system for diagnosing COVID-19 variants at this year’s European Congress of Clinical Microbiology, the ECCMID. Seegene’s Dr. Guy Willem Lee, Director of Marketing Strategy introduced the diagnostic system under the theme of “SARS-CoV-2 and Variants ‘Full Screening’ Solution” using its latest COVID-19 variant diagnostic tests. “The backdrop of Korea’s outstanding control at the onset of the pandemic is because of the one-platform diagnostic system that enables mass testing,” said Lee. He added that “the system enabled the diagnostic process from sample collection through PCR testing all at once, helping local authorities to quickly control the pandemic.” The effectiveness of the current diagnostic system, however had been put to question due to a growing number of COVID-19 variants spreading fast, with reports saying vaccines may not offer enough protection against them. The Centers for Diseases Control and Prevention have previously said variants are poised to drive an increase in new cases in the U.S. in May after having projected that the global COVID-19 cases will sharply increase over the continuous surge in variants. Referring to Seegene’s ‘Full Screening Solution,’ Director Lee proposed that the system will efficiently help counter the protracted COVID-19 pandemic. The ‘Full Screening Solution’ is a one-step system that can verify whether an individual has contracted coronavirus wildtype or the virus variant with a single real-time PCR test. Currently, health authorities are forced to go through an extra round of genomic sequencing to distinguish the existence of COVID-19 variants after standard PCR tests, automatically leading to a more prolonged testing time. Against the backdrop of Seegene’s ‘Full Screening Solution’ are the company’s latest variant diagnostic tests, the AllplexTM SARS-CoV-2 Master Assay and AllplexTM SARS-CoV-2 Variants I Assay. The AllplexTM SARS-CoV-2 Master is an ideal way of screening for the COVID-19, as it provides results of whether a person is positive of the COVID-19 or even its variants. After an initial round of testing, Seegene’s AllplexTM SARS-CoV-2 Variants I Assay will help identify multiple mutant variations in a single reaction. The AllplexTM SARS-CoV-2 Master Assay can detect a total of 10 targets including four coronavirus genes (E gene, RdRP gene, N gene and S gene) as well as five defined virus variants notably spotted in the most recognized lineages including B1.1.7, B.1.351, P.1 and B.1.1.207. Seegene’s variant diagnostic test is the first such kind to simultaneously detect multiple coronavirus genes and differentiate virus variations, including those found to be more contagious and fatal. It’s an ideal and an economic way of screening coronavirus genes as the pandemic continues to rage with both the wildtype and its virus variants. Director Lee added “Seegene’s ‘Full Screening Solution’ will play a critical role in controlling the spread of COVID-19 pandemic amid fast spreading virus variants.” Also at this year’s world scientific symposia, Dr. Nakmoon Sung of Seegene Medical Foundation announced outcomes of clinical researches on the detection of SARS-CoV-2 mutations, known to be associated with the variants, as well as the detection of coinfections with respiratory pathogens among COVID-19 patients. Among the COVID-19 positive cases, the proportion of SARS-CoV-2 with the COVID-19 variant associated mutations have surged to 3.5% in late February from the 1.2% a month earlier. Such clinical researches show that Seegene’s diagnostic tests are capable of screening COVID-19 and screen for variants with single PCR test. Looking at the coinfection cases, 8.8% of COVID-19 positive cases have also been coinfected with respiratory diseases including Flu A, RSV, rhinovirus, metapneumovirus and Mycoplasma pneumoniae. Reflecting on the clinical data, Dr. Sung said “swift diagnostic system is extremely critical in helping to control the resurgence of the COVID-19 pandemic,” and added that “the one-step and accurate diagnostics will become the global standard in detecting coronavirus and other respiratory diseases, for the purpose of accurate treatment”
May 24, 2021View Detail >
- SEEGENE POSTS KRW 193.9 BIL. IN OPERATING PROFIT, UP 388% ON-YEAR - OPERATING PROFIT RATIO AT 55%, DESPITE CONSTANT INVESTMENT IN R&D AND EMPLOYEES Seegene Inc. (KQ 096530), a molecular diagnostics company reported its financial results for the first quarter of 2021, with reports showing robust earnings. The biotechnology firm posted KRW 351.8 billion in consolidated revenue, a 330% increase compared to the same period last year and a record for the first quarter. Operating profit at KRW 193.9 billion, also up 388% on-year, reflecting steady growth in its sales of diagnostic tests. Seegene’s Senior Managing Director of IR and PR Department Myungkun Kim said “the company was able to manage 55% of annual operating profit ratio, a clear reflection of its ability to effectively manage the firm despite the constant investment in R&D and expansion of manpower.” He added that “once investments come to fruition, the operating profit ratio will likely surge even further.” Kim added “Seegene’s thriving performance had been backed with continuous surge in demand for variant diagnostic tests and as more governments around the world are reeling back to normalcy with mass examinations at schools and workplaces.” He said the company is expected to see additional surge in sales through entering new markets as well as launching new products and technologies.” The head of IR and PR Dept. added that “although the second quarter is predicted to show comparable sales volume to that of the first quarter, due to a delay in supply deals being reflected onto actual sales figures, the latter half of the year however looks even more promising.” Seegene had previously secured public procurement for COVID-19 diagnostic tests in Italy worth over EUR 89.3 million, a separate public tender agreement in Scotland worth 16,209,150 GBP and a supply deal in Germany worth EUR 19.3 million.
May 12, 2021View Detail >
Apr 10, 2020View Detail >