Real-time test differentiates influenza A & B, RSV and COVID-19SEOUL, South Korea (March 1, 2021)— Seegene Inc., (KQ096530), a biotechnology company specializing in molecular diagnostics, has submitted its Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA). Seegene's Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay is a real-time RT-PCR assay that can simultaneously detect and differentiate 8 target genes including Flu A, Flu B, RSV A/B and three different target genes of COVID-19 (S gene, RdRP gene and N gene). The assay also includes dual targets for internal control (endogenous and exogenous respectively) in the same reaction tube, also Seegene’s unique channel of allowing for verification of the whole test process, as well as proper sampling, without having to compromise the accuracy of test results. The Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay is currently available in Europe and elsewhere around the world.“Demand for accurate and available COVID-19 testing remains high across the United States,” said Dr. Jong-Yoon Chun, CEO of Seegene. “This multiplex assay will provide clinicians with the ability to differentiate diagnosis between the common flu and COVID-19. It is also incredibly efficient for labs because they will only need to run a single test versus four different tests. We’re committed to bringing innovative solutions to the market and doing our part in the fight against this pandemic.” Such technological advancement not only saves time and cost in testing for the novel Coronavirus, but improves overall process efficiency, enabling massive testing, essential in fighting the COVID-19 pandemic.“COVID-19 testing will continue to play a vital role in reopening and resuming regular operations in businesses and schools,” said Helen Cha Roberts, President at Seegene Technologies, USA. “EUA approval of Seegenes’s Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay will ensure that facilities have the most advanced testing available to help quickly identify those infected with the virus and curb the spread. Seegene is well-positioned with inventory and a support team based in the U.S. to meet the continued demand."Seegene, a global innovator in molecular diagnostic technology has been a leader in developing COVID-19 diagnostic assays to fight the pandemic. Last year, the company developed the Allplex™ 2019-nCoV Assay by leveraging the company’s artificial intelligence-based data system and advanced high multiplex real-time PCR technology and chemistry. The Allplex™ 2019-nCoV Assay and Seegene’s subsequent family of Allplex™ SARS-CoV-2 tests have become the most widely COVID-19 tests used in South Korea due to their rapid results and vital details on infectious species and strain. The Allplex™ 2019-nCoV Assay test kits have been deployed in more than 65 countries around the world. High Demand for COVID-19 TestingWidescale testing is a proven mitigation strategy to prevent the spread of COVID-19. As such, President Biden’s COVID-19’s plan aims to ramp up the number of testing sites and increase the production of rapid tests in order to ensure that every person in the country can be tested regularly. The Rockefeller Foundation forecasts that K-12 schools alone would need approximately 300 million tests to be performed each month from February through June to successfully reopen in-person learning. Additionally, an October 2020 McKinsey & Company report also noted that with the addition of flu-like symptoms—which are similar to COVID-19 symptoms, demand for COVID-19 testing could show a threefold increase during the winter months of 2021.About Seegene, Inc.Founded in Seoul, South Korea in 2000 and with subsidiaries in the U.S.A., Canada, Germany, Italy, Mexico, Brazil, and the Middle East, Seegene, Inc. is an in-vitro diagnostics (IVD) company that has been turning concepts into products through its pioneering R&D activities. Seegene owns its original patent technology including DPO™ (Dual Priming Oligonucleotide) for multiple target amplification; TOCE™, for multiple target detection in a single channel; MuDT™, the world’s first real-time PCR technology that provides individual Ct values for multiple targets in a single channel for quantitative assays.; and mTOCE™ multiplex mutation detection technology. With these cutting-edge molecular diagnostic (MDx) technologies applied to diagnostic kits and other tools, Seegene has enhanced the sensitivity and specificity of PCR (polymerase chain reaction) to unprecedented levels, providing multiplex PCR products that target and detect genes of multiple pathogens simultaneously, saving testing time and cost. Seegene continues to set new standards in MDx providing new, cost-effective innovations.Contact:Seegene, Inc.Ashlee Semin ShinP: +82-2-2240-0685E: email@example.comU.S. Media Contact:Kristin SchaefferP: +1 814-360-0660E: firstname.lastname@example.org
Mar 03, 2021Ver Detalles >
- SEEGENE ROLLS OUT FIRST COVID-19 MUTANT IDENTIFICATION TEST - COVID-19 TEST MANUFACTURER CONTINUES TRACKING VARIANTS - S. KOREAN FIRM COMMITTED TO WORKING WITH GOVERNMENTS South Korea’s biotechnology firm Seegene (KQ096530) said Monday it developed the world’s first COVID-19 diagnostic variant test, capable of screening COVID-19 and identifying multiple mutant variations in a single reaction. Seegene’s new variant test, the ‘Allplex™ SARS-CoV-2 Variants Ⅰ Assay,’ can detect and differentiate virus variations, including those found to be more contagious and fatal. The new variant test not only detects COVID-19, but can also identify major genetic variations that seem to have originated from the UK, South Africa as well as other regions including Japan and Brazil. Furthermore, it can pre-screen a suspicious new variant, providing insight on additional variations, also a key feature of Seegene technology. Seegene’s new product integrates at least ten of its proprietary technologies, including multiplex real-time PCR method of mTOCE™, which is the cutting-edge technology that only Seegene can leverage. This innovative technology allows the test to detect a target specific spot where mutation occurs, enabling precise detection and differentiation of the coronavirus as well as its mutated versions with a single tube of reagent. Another key feature using Seegene’s unique technology is its endogenous internal control that can verify entire testing process including proper sample collection. By utilizing Seegene’s big data auto-surveillance in silico system, the company is closely monitoring and analyzing worldwide database on COVID-19 and its variants, allowing it to quickly respond with product development. Currently governments and health authorities around the world are forced to rely on individual sample sequencing, which is unsuitable to massive testing, to filter out virus variants from COVID-19 positive cases. An official from Seegene said its “new COVID-19 diagnostic variant test will significantly boost massive testing ability in its fight against the global-spread of mutant viruses when the time is key to controlling the pandemic.” The current diagnostics relies on PCR test or rapid antigen/antibody test to diagnose COVID-19 infection or the existence of antibodies. But the current diagnostic methods have limitations in screening virus variants, putting the brakes on effective epidemic prevention. Only PCR method can screen and identify the variants, but doing that in a single tube of reagent had not been possible until Seegene’s new variant test. According to the company official, Seegene plans “to supply its COVID-19 variant tests to global organizations and governments as its priority.” The official added that the company will continue its work to “fulfill the duty as a leading global molecular diagnostics company by closely working with health authorities around the world.”
Feb 01, 2021Ver Detalles >
South Korea's biotechnology company specializing in molecular diagnostics, Seegene Inc. (KQ096530) said Tuesday that it has CE-IVD marked the saliva-based testing application for Allplex™ SARS-CoV-2 Assay and Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay, and that the products with the feature are now available in Europe. The new addition of saliva sample collection feature is set to offload burden of collecting large volume of specimen samples for healthcare professionals on the frontlines of the COVID-19 pandemic. With the newly added feature, the saliva sample collection test can be used interchangeably with nasopharyngeal specimen collection test, normally used for multiplex real-time PCR tests for screening the novel coronavirus. Korea’s leading molecular diagnostics firm said its saliva sample collection test provides additional option for the easy, safe and convenient sample gathering without having to compromise sensitivity and specificity of the test. Separately, a study conducted by Children’s National Hospital in Washington DC taken in the July-to-September period in 2020 showed Seegene’s Allplex™ 2019-nCoV Assay, an earlier version of the company’s COVID-19 diagnostic test, was found to be best suited among the four competing FDA EUA-approved COVID-19 PCR assays for testing saliva specimens collected from participants. It added that the sensitivity of viral detection was equivalent to that of nasopharyngeal specimens when tested on Seegene’s Allplex™ 2019-nCoV Assay. Seegene’s saliva sample collection feature can also eliminate the need for materials and labor associated with nucleic acid extraction, as the test is being performed directly from the raw saliva collected from participants. An official from Seegene said the saliva sample collection feature, together with the extraction-free application, also CE-IVD marked in November, will enable labs to carry out massive testing. The extraction-free application allows labs without extraction equipment, previously a prerequisite for molecular diagnosis testing, and was recently made available in Europe for Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay. Presenting the company’s first ever saliva specimen collection test, an official from Seegene said the new feature is deemed an efficient method of collecting large volume of specimens, especially at a time when mutant coronavirus in Europe has recently prompted global alarm rly December and has exported more than 55 million COVID-19 tests to more than 60 countries in the first three quarters this year. The company recently announced its plans to expand its annual production capacity to KRW 5 trillion by early next year.
Jan 07, 2021Ver Detalles >
Seegene Inc. (KQ096530), a South Korean biotechnology company specializing in molecular diagnostics says it has donated 20,000 COVID-19 tests (Allplex™ SARS-CoV-2 Assay) to Ecuadorian government to help fight the COVID-19 pandemic together. The South Korean company said the COVID-19 tests will be distributed to National Institute for Public Health Research (INSPI) in capital city of Quito and Cuenca as well as to Quito city government. Ecuador's health ministry said as of Tuesday this week, the country has a total of 202,356 confirmed COVID-19 cases with the death toll standing at 9,357. South Korea's leading molecular diagnostic manufacturer said it anticipates the COVID-19 tests will support caregivers in times of need, and added that it also hopes to counter the rapidly spreading virus across South America. It also stressed that in order to curb the spread of coronavirus, the speed of testing should be faster than that of infection. Earlier in November, Ecuador's Foreign Minister Luis Gallegos visited Seegene headquarters in Seoul and expressed gratitude saying that Ecuador is "thankful for Seegene's generosity in donating diagnostic tests." Gallegos added the donations "will become a very meaningful contribution to our government and Ecuadorian people." Seegene had previously contributed COVID-19 tests to government entities and non-profit organizations in the U.S. and to Mexico's health ministry. The company says it plans on supporting communities and governments around the world in the prolonged battle against the COVID-19 pandemic. Seegene's aggregated annual sale surpassed KRW 1 trillion early December and has exported more than 55 million COVID-19 tests to more than 60 countries in the first three quarters this year. The company recently announced its plans to expand its annual production capacity to KRW 5 trillion by early next year.
Dec 17, 2020Ver Detalles >
South Korea’s biotechnology company specializing in molecular diagnosis, Seegene Inc. (KQ096530), announced Monday that its aggregated sales this year have already surpassed the KRW 1 trillion mark, up nearly 10 times its previous annual sales of KRW 120 billion in 2019. This is largely due to an exponential surge in demand for both molecular diagnostic test kits and according PCR instruments, critical in accurately diagnosing patients. Riding on the robust growth in sales, Seegene said it plans on raising its annual production capacity to KRW 5 trillion from the current KRW 2 trillion by the first quarter of 2021. The company’s five production facilities are located in Hanam City, in the vicinity of capital Seoul. Additionally, Seegene recently purchased 10,752 square meters of land in Hanam City, able to handle even greater global demand in the future. With the COVID-19 pandemic, the sales of not only the COVID-19 test kits but the demand for those of other illnesses such as HPV, gastrointestinal infections and sexually transmitted infections also increased significantly. With Seegene’s diverse diagnostic reagent products numbering more than 150, there has been an increasing trend throughout the world to install Seegene’s PCR instruments, which in turn would generate more long-term sales. The company installed more PCR instruments in November alone than it did in the entire year of 2019. As a way to share profit with its shareholders, Seegene also announced that it will boost dividend payouts by a whopping 15 folds to KRW 1,500 for the 2020 fiscal year. The molecular diagnostics firm said it will begin releasing preliminary quarterly earnings disclosure for swift information sharing with the public. An official from Seegene said the ‘COVID-19 pandemic both expanded the molecular diagnostics market and raised Seegene’s brand awareness to the healthcare professionals, government officials and the general public alike.’ He added the ‘demand for molecular diagnostic test to identify coronavirus patients will remain intact even with the introduction of vaccines.’ Learning from the experience of the pandemic, the official added that even ‘in the post COVID-
Dec 14, 2020Ver Detalles >
Apr 10, 2020Ver Detalles >
Apr 07, 2020Ver Detalles >