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ㆍ Q1 revenue up 10% QoQ to reach record quarterly high of KRW 451.5 billionㆍ Foundation for sales expansion strengthened through ‘3 Ct’ technology commercialization, Allplex™ RV Master Assay approval, increased PCR instrument salesㆍ “Seegene to secure future growth by targeting syndromic testing market, expanding U.S. operations, M&A” SEOUL (May 13, 2022) Seegene Inc. (KQ096530), South Korea’s leading molecular diagnostics (MDx) company, today reported first quarter revenue of KRW 451.5 billion and operating profit of KRW 199.7 billion.Total sales rose 10% quarter-over-quarter to reach a record quarterly high, driven by increased PCR demand due to a surge of the Omicron variant. Operating profit was comparable to the previous quarter’s KRW 199.9 billion.During the first quarter, Seegene developed ‘Allplex™ HPV HR Detection,’ the world’s first commercialized assay applying ‘3 Ct’ technology that enables reporting three Ct values in a single channel for quantitative analysis. Seegene also obtained approval from the European Union and Australia for ‘Allplex™ RV Master Assay’ that can simultaneously detect 19 different respiratory viruses, including COVID-19. The company also established a branch in South Africa.As for PCR instruments, Seegene newly installed 360 real-time PCR detection systems and 261 workstations for extraction and PCR setup, for a combined 5,214 and 2,543 respectively worldwide, solidifying the foundation for expanded global sales.The company has also created a team to ramp up ESG (Environmental, Social, Governance) management.“As PCR demand is declining worldwide, it will likely impact our revenue,” said Robert Lee, Senior Vice President of Seegene’s IR and PR department, adding that “Seegene will secure future growth by targeting the syndromic testing market for respiratory viruses and other illnesses as well as expand the utilization of PCR testing with the company’s fully automated MDx system, AIOS.”Going forward, Seegene plans to establish R&D and production facilities within the United States to bolster operations and pursue M&A to achieve mid-to-long term growth.
May 16, 2022View Detail >
ㆍProvides Ct value of three targets in one channel; ‘3 Ct’ PCR assay to launch in H1 ㆍ“Dream MDx technology” developed based on Seegene’s 20-year expertise; combines 19 different patent technologies, including DPO™, TOCE™, MuDT™ ㆍ‘3 Ct’ to lay foundation for automated syndromic testing and make MDx more accessibleSouth Korea’s leading molecular diagnostics (MDx) company, today announced the development of the world’s first commercialized PCR assay applying ‘3 Ct’ technology. The ‘Allplex™ HPV HR Detection’ was showcased at the 2022 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) held April 23-26 in Lisbon, Portugal.In a polymerase chain reaction (PCR), the cycle threshold (Ct) value is used to quantify the concentration of a viral DNA sequence (the target). Due to technological limitations, the conventional real-time PCR technique finds the Ct value of one target in one channel.But Seegene’s ‘3 Ct’ technology can provide the Ct value of three targets in one channel without compromising sensitivity and specificity. The successful development is based on Seegene’s 20-year expertise and combines 19 different patent technologies, including DPO™, TOCE™, and MuDT™. Using five channels in a single tube, Seegene can provide quantitative data for a total of 15 targets. ‘3 Ct’ has been dubbed the “dream MDx technology.”The company plans to apply ‘3 Ct’ technology to its entire product line-up, including respiratory virus (RV), sexually transmitted infection (STI), gastrointestinal infection (GI), and urinary tract infection (UTI) assays. Seegene expects ‘3 Ct’ technology to take syndromic testing to another level. By detecting the causative pathogen, level of infection, and potential of co-infection, it will help determine the priority of treatment and enhance patient management. ‘3 Ct’ technology also increases testing capacity. Such features are expected to improve the service and cost-structure of the medical sector once ‘3 Ct’ technology is widely utilized.Seegene’s first ‘3 Ct’ technology applied product, Allplex™ HPV HR Detection, is designed to detect 14 high-risk human papillomavirus (HPV) types that can cause cervical cancer (see figure 1). It also provides the individual Ct value of each of the types allowing quantitative analysis regarding infection level. Early detection of HPV contributes to the prevention and management of cervical cancer. HPV products from other industry players provide individual Ct values for two high-risk types, HPV 16 and 18. The Allplex™ HPV HR Detection, planned to be launched within the first half of this year, will come with a significant cost advantage compared to existing HPV products to increase accessibility to PCR testing, which had been difficult previously due to high costs. The product will also be compatible with Seegene’s fully automated AIOS (all-in-one system). The company plans to introduce the industry’s first ‘fully automated, mass, syndromic testing system,’ to lay the foundation for testing anywhere, including large hospitals, C-Labs, and even small and medium-sized clinics, and make PCR testing part of everyday life.“HPV genotyping is essential for a good follow-up of a patient to observe the emergence, persistence or clearance of each genotype,” says HPV expert Sebastien Hantz, Professor at the Faculty of Medicine at the University of Limoges in France. “Seegene is a company very involved in the development of molecular diagnostics tests for the detection of different pathogens. For certain clinical situations, like respiratory infections, syndromic testing is very useful.”[Figure 1] Seegene unveils world’s first commercialized ‘3 Ct’ PCR technology
Apr 27, 2022View Detail >
South Korea’s leading molecular diagnostics (MDx) company, today announced that its Allplex™ RV Master Assay has received approval from Australia’s Therapeutic Goods Administration and achieved the European CE-IVD marking.Therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be supplied in the country. The CE-IVD marking is a legal requirement for marketing medical devices in the European Union.Seegene’s Allplex™ RV Master Assay can distinguish 21 targets for 19 different respiratory viruses, including COVID-19, flu, and common colds. Specifically, the assay can identify three genes of COVID-19, Flu A, Flu B, metapneumovirus, two types of respiratory syncytial virus, four types of parainfluenza virus, six types of adenovirus and three types of human rhinovirus (see table 1).The Allplex™ RV Master Assay was developed based on Seegene’s decades-long know-how and applies patent technologies, like DPO™, TOCE™ and MuDT™ (see table 2). The syndromic test allows medical specialists to swiftly find out which viruses are making the patient sick with a single sample.The world has turned its focus to living with COVID-19 endemically and relaxed social distancing and mask restrictions have created an environment for various respiratory viruses to circulate with ease.Recent data from FluTracking, a surveillance system used to detect influenza in Australia, found 10-15% of respondents with fever and cough symptoms in some cities, as the southern hemisphere heads into the winter season.Seegene’s independent clinical test recently conducted in Europe using the Allplex™ RV Master Assay on 1,928 people also found that 16.5% (318 people) tested positive for respiratory viruses, excluding COVID-19. Of that figure, 6.9% (22 people) had contracted two or more viruses.Symptoms of COVID-19, such as coughing and fever, can also be a sign of other respiratory infections. This makes it difficult to identify the exact viral cause and the appropriate treatment for each patient. Testing is critical for proper care as treatments can vary by infection type and to reduce the potential of co-infection.A study published in The Lancet shows that patients that contracted both COVID-19 and flu had more than double the risk of death, while the need for invasive medical ventilation jumped by four-fold.The Allplex™ RV Master Assay has been designed in consideration of such circumstances as countries shift policies to get everyday life back to normal.“Allplex™ RV Master Assay can detect respiratory viruses that can occur all-year round to simplify the diagnostic of the ‘new normal’ respiratory virus composition,” said Dr.Tove Havnhøj Frandsen, of Sygehus Sonderjylland (Hospital of Southern Jutland)/RenTov Consult, who led Seegene’s clinical test in Europe. ”The assay is expected to be well-utilized as winter approaches in Australia and South America and as the world turns to live with COVID-19 endemically.” Table 1. Allplex™ RV Master Assay targets VIRUS VIRUS SUB-TYPE COVID-19 (Target gene) COVID-19 (S, N, RdRP gene) Influenza A Influenza A Influenza B Influenza B Metapneumovirus (MPV) MPV Respiratory Syncytial Virus (RSV) RSV A, RSV B Parainfluenza virus (PIV)> PIV1, PIV2, PIV3, PIV4 Adenovirus (AdV) AdV A, AdV B, AdV C, AdV D, AdV E, AdV F Human Rhinovirus (HRV) HRV A, HRV B, HRV C Table 2. Seegene's patent technologies DPO™ (Dual Priming Oligonucleotide) Multiple target amplification technology that enhances target specificity and minimizes non-specific amplification commonly occurred in multiplex PCR TOCE™ (Tagging Oligonucleotide Cleavage and Extension) Oligonucleotide chemistry solution for homogenous high multiplex real-time PCR. TOCE technology enables detection and differentiation of multiple targets in single fluorescence channel through melting temperature analysis MuDT™ (Multiple Detection Temperatures) Analytical real-time PCR technology which enables detection of multiple targets with individual Ct value in single channel without melting curve analysis
Apr 06, 2022View Detail >
Dr. Hansen to provide clinical input to product development process; strengthen strategic partnerships with U.S. networksSecond leadership announcement for U.S. subsidiary in a monthSouth Korea’s leading molecular diagnostics company, today announced the appointment of Glen Hansen, Ph.D., D(ABMM), FCCM, as the Head of Scientific and Medical Affairs of its United States subsidiary, Seegene Technologies. In this role, Dr. Hansen will provide clinical input to the development process of new products and initiate product and disease state knowledge to targeted medical and scientific thought leaders.Dr. Hansen has decades of real-world and clinical experience as a microbiologist specializing in molecular diagnostics and medical microbiology. Prior to joining Seegene, he was the Medical Director of the Microbiology and Molecular Diagnostics Laboratory at Hennepin County Medical Center in Minneapolis and the University of Minnesota School of Medicine. Dr. Hansen graduated with honors from the University of Saskatchewan where he earned dual bachelor’s degrees in Microbiology and Immunology. He later received his Ph.D. in Clinical Microbiology. His post-doctoral experience includes a fellowship in Molecular Diagnostics (New York University/New York Public Health Research Institute) and in Medical Microbiology and Public Health Microbiology (University of Washington).“I’m excited to utilize my years-long clinical experience at Seegene Technologies and be at the forefront of the company’s transformation of its assay development process from manual to digital,” said Dr. Hansen. “The vision is to expand our product portfolio ranging from COVID to non-COVID assays, to open a new paradigm in molecular diagnostics and enable health professionals to select the most reliable and effective treatment for patients.”Dr. Hansen’s appointment marks the second leadership announcement for the U.S. subsidiary in less than a month. In late February, Seegene appointed Richard Creager, Ph.D., as the CEO to help solidify its U.S. business and deliver on the company’s global strategy as a molecular diagnostics platform company, through product development, M&As and strategic alliances.“This appointment greatly strengthens Seegene’s presence in the U.S. as the company aims to drive the adoption and clinical utilization of its products and increase strategic partnerships with U.S. health networks and research institutions,” said Dr. Creager, CEO of Seegene Technologies. Seegene will also add a Chief Financial Officer to its U.S. leadership lineup at the end of March. The company expects the latest appointments to help Seegene Technologies broaden its horizon of operation, from sales to R&D, local production and financial affairs, as it aims to increase its share in the U.S. molecular diagnostics market.
Mar 18, 2022View Detail >
Dr. Creager to lead U.S. business from R&D, local production to M&A“Thrilled to create synergy to help Seegene grow as a top global molecular diagnostics company through success in U.S.”South Korea’s leading molecular diagnostics company, today announced the appointment of Richard S. Creager, Ph.D., as the CEO of its United States subsidiary, Seegene Technologies. Dr. Creager brings decades of real-world in vitro diagnostics business and molecular diagnostics (MDx) experience to the role, in which he will execute business strategies in the U.S.Dr. Creager holds a Ph.D. in Microbiology from the University of Pittsburgh School of Medicine. As a former chief science officer and executive officer for Beckman Coulter, he has a diverse experience in developing new products, technologies and business models for diagnostic, laboratory services and B2B companies. With Dr. Creager’s expertise in organizational design, talent management, product development, program management, and quality & design control systems, Seegene expects him to help create momentum to expand and strengthen its business in the U.S. and replicate its success story seen in other global MDx markets.The company has been under the global spotlight as an early assay provider during the COVID-19 pandemic thanks to its unique multiplexing capabilities and automated assay development system. However, its presence has been relatively limited in the U.S., the world’s largest molecular diagnostics market, until now. Dr. Creager will closely collaborate with Seegene Headquarters to foster new growth drivers and deliver on the company’s global strategy and mission as a molecular diagnostics platform company, through product development, M&A, and strategic alliances.“I have supported many companies in solidifying the strategic direction of their molecular diagnostics technologies,” said Dr. Creager. “Seegene is, by far, one of the most outstanding companies I’ve seen in terms of diagnostics assay technology. I am thrilled to help Seegene build upon its worldwide success by establishing a leading enterprise in the U.S.”
Mar 03, 2022View Detail >
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Jul 09, 2021View Detail >