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Test detects 21 targets for 19 respiratory viruses in single tube, including COVID-19 and fluAssay result of Seegene’s decades-long know-how, applies DPO∙TOCE∙MuDT technologies “Optimal solution for safe return to normalcy as distancing restrictions eased”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 make testing 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, 2022Ver Detalles >
- Scheduled to launch in late January, Seegene’s new COVID-19 test supports swift, large-scale lab testing with the same degree of accuracy as the conventional PCR testSeegene Inc. (KQ 096530), South Korea’s leading molecular diagnostics company, announced today the upcoming launch of the Allplex™ SARS-CoV-2 Fast PCR Assay, which can deliver PCR results in just 60 minutes. The company says that this assay is expected to reduce the total turnaround time to a third and expand testing capacity up to 3 times for hospitals and laboratories without additional instruments or compromise on accuracy.Reduction of the turnaround time was attributable to two primary reasons: 1) the application of a novel enzyme developed by Seegene, which reduces PCR process time to half. 2) Seegene’s innovative extraction-free method, which can let Allplex™ SARS-CoV-2 Fast PCR Assay be available without the extraction of the sample preparation in PCR-based tests. This drastically reduces the total turnaround time for each result. As such, the new assay lessens the amount of hands-on processing time required, allowing facilities to triple their testing capacity in the same hour.“This assay will be the optimized choice for laboratories and hospitals where they conduct large-scale testing as it helps them immediately expand the testing capacity with lessening the burden of healthcare workers,” said Ho Yi, Chief Sales and Marketing Officer of Seegene. "For the time being, we plan to target large-scale testing markets in more than 60 countries all across the globe. The next step in our journey is to develop a new gold-standard molecular diagnostic assay that fully matches the speed of antigen tests with the same degree of accuracy as PCR test”The Allplex™ SARS-CoV-2 Fast PCR Assay targets three COVID-19 genes––E, RdRP, and N–– to reliably detect COVID-19 regardless of the variants. According to clinical research conducted by 17 laboratories in seven countries, this assay showed the same or better accuracy for the COVID-19 detection as other diagnostic tests available in the market.
Jan 19, 2022Ver Detalles >
- Seegene to export COVID-19 test that detects COVID-19 and Omicron along with its Master Assay that distinguishes between COVID-19 and other respiratory viruses Seegene Inc. (KQ 096530), South Korea's leading molecular diagnostics company, announced today that it has delivered over five million COVID-19 tests to Israel to help detect and mitigate the spread of the Omicron variant. The company sent 1.7 million diagnostic tests and associated consumables in December 2021, while additional 3.4 million tests are scheduled to be delivered in January. Like much of the world, Israel started to experience a shortage of COVID-19 tests as Omicron was driving an unprecedented surge in cases. More seriously, the number of flu or ‘flurona’ patients who may be co-infected with flu and COVID-19 seems to increase this winter. Seegene’s prompt delivery of COVID-19 tests is expected to cover approximately 57% of Israel’s total 9 million population and play a crucial role in controlling the potential ‘twindemic’ season. “We will continue to support countries in need of COVID-19 tests to improve global health,” said Dr. Jong-Yoon Chun, Seegene Founder, and CEO. “It is apparent that Seegene’s accurate COVID-19 tests screening all COVID 19 variants and syndromic tests with the respiratory essential panel are going to be a key to the global effort of returning to normal. Both tests will also help to manage lives with COVID-19 and other respiratory infections.” Seegene will send various products to Israel, including its Allplex™ SARS-CoV-2 Master Assay and Allplex™ SARS CoV-2 FluA/FluB/RSV Assay.- Seegene's Allplex™ SARS-CoV-2 Master Assay can quickly determine the spread of the new Omicron variant in real-time with multiplex PCR technology, rapidly identifying positive cases and those variants in a single reaction.- Allplex™ SARS CoV-2 FluA/FluB/RSV Assay can determine the exact cause of respiratory symptoms. A single test can distinguish between Influenza A and B, RSV, and COVID-19.
Jan 17, 2022Ver Detalles >
- Seegene’s syndromic assay detects COVID-19 and Influenza A/B/RSV infections in a single test.Seegene Inc. (KQ 096530), South Korea's leading molecular diagnostic company, announced it has received approval of its Allplex™ SARS CoV-2 FluA/FluB/RSV Assay under Health Canada's Interim Order on January 11.Seegene’s Allplex™ SARS CoV-2 FluA/FluB/RSV Assay is a multiplex real-time PCR assay that enables simultaneous amplification and differentiation of respiratory symptoms. In a single test, it can distinguish among Influenza A, B, RSV, and COVID-19. This assay expected to play a crucial role in responding against the potential ‘twindemic’ as the country is forecasting a surge in both flu patients and COVID-19 patients.To support Canada experiencing surging demand for COVID-19 tests, Seegene delivered 340,000 COVID-19 tests to Canada by a charter flight on January 13.“Demand for COVID-19 tests is skyrocketing due to the resurgence of confirmed cases,” said Ho Yi, Chief Sales and Marketing Officer of Seegene. “We are fully prepared to supply enough test kits globally and will continue to be strong global partners in the effort to manage the spread of COVID-19.” This latest approval is expected to be a significant opportunity for the company, as it will allow Seegene to raise its product awareness in surrounding countries of Canada such as Latin America and others.
Jan 17, 2022Ver Detalles >
Seegene Inc. (KQ 096530), South Korea’s leading molecular diagnostics (MDx) company, today, unveiled its blueprint for the future during a presentation at the 40th annual J.P. Morgan Healthcare virtual Conference. Dr. Jong-Yoon Chun, CEO of Seegene, proposed three strategic solutions that induce the world ‘back to normal’ against the COVID-19 pandemic. Along with three solutions, he also introduced the company’s automated, AI-enabled platform with a standard development tool that will empower users to easily develop their own diagnostic assays. Three solutions for ‘back to normal’In preparation for returning to normal in 2022, Dr. Chun outlined three solutions. △First, it starts with Seegene’s on-site screening solution for mass testing with its fully automated MDx system at various facilities including schools, airports, workplaces, and others. It provides a short turnaround time, economic price, and improved accuracy even for asymptomatic cases, which cannot be detected by rapid antigen tests. △The second solution is Seegene’s centralized screening system, with its newly developed diagnostic test that can multiply the test capacity without additional instrument investments in the laboratories. △The third solution is syndromic testing for patients with respiratory symptoms. Seegene had already introduced Allplex™ RV Master Assay that can simultaneously differentiate ten targets including COVID-19, Flu, and common respiratory viruses. This assay is the key to open a path towards normalcy as it identifies the exact cause of respiratory symptoms. Strategic shift to a MDx platform companyDuring the presentation, Dr. Chun unveiled Seegene’s strategic shift as a molecular diagnostics platform company, introducing Seegene’s MDx platform for assay development. Until now, commercial MDx development has been a labor-intensive manual process requiring highly skilled researchers and significant resources. “Our digitalized open development platform will overcome the limitations of the current paradigm of MDx development processes by allowing users to rapidly design and efficiently develop their own diagnostic assays”, said Dr. Chun. “We are pleased to provide our technologies, software and know-how to support rapid and standardized assay development which will eventually help accelerate the use of MDx in our daily lives.” Seegene’s MDx platform integrates proprietary technologies and development know-how that Seegene has developed over the last two decades, with artificial intelligence (AI)-based automated design system. This platform allows platform users, regardless of knowledge and experience in MDx, to develop high multiplex real-time PCR assays, which will eventually fulfill unmet testing needs at a local level. Finally, Dr. Chun stated the vision that Seegene stepped ahead to a new horizon by evolving to MDx platform company. Through all these efforts, Seegene will ultimately bring MDx into our daily life. The full video of the CEO’s remarks will be available after the event at www.seegene.com/ir_event.
Jan 13, 2022Ver Detalles >
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