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, 2021View Detail >
- Seegene’s new product filters COVID-19 and variants during primary PCR testing in 1 hr 55 min - Seegene’s proprietary high multiplex technology enables detection of 10 different targets - S. Korean firm to research additional versions of variant diagnostic tests Seegene (KQ096530), a biotechnology company specializing in molecular diagnostics, said Wednesday it finished the development of the world’s first-ever variant diagnostic test that can simultaneously detect COVID-19 and screen multiple virus variants, with a single multiplex real-time PCR testing. The ‘Allplex™ SARS-CoV-2 Master Assay’ can detect both coronavirus and its variants in the initial round of testing. It’s an ideal way of screening coronavirus genes, as the pandemic continues to rage after being coupled with more contagious variants that have spread to at least 70 countries. The new COVID-19 test detects 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. Those variants include B.1.1.7 (U.K. lineage of concern, associated with the N501Y mutation), B.1.351 (South African lineage defined by 501Y.V2), P.1 (Brazilian lineage with variants of biological significance E484K, N501Y and K417T), B.1.1.207 (U.S. lineage). Detecting four coronavirus genes in a single tube of assays can only be realized by Seegene and its unique technology, one that is extremely vital when distinguishing the virus that keeps on evolving at a fast rate. Seegene’s technology can precisely detect various types of mutant variants including those of point mutation and deletion of amino acids. Additionally, Seegene’s ‘Allplex™ SARS-CoV-2 Master Assay’ can pre-screen suspicious new variants that are believed to carry composition of the already discovered mutations. Recently multiple COVID-19 mutations have been reported to overlap, like the N501Y mutation, now being spotted in multiple lineages, after having been reported in the U.K. and South African variants. ‘Allplex™ SARS-CoV-2 Master Assay’ can also be used in conjunction with ‘Allplex™ RV Essential Assay,’ a one-step assay for screening 17 target causative viruses for respiratory infections. With a single swab sample, the two provide high usability in detecting essential respiratory pathogens accurately and comprehensively. Seegene also utilized its original technology of endogenous internal control system that verifies entire testing process, starting with the sample collection, making the less-invasive saliva sampling method a viable option. The company added the extraction-free application is currently under development. The extraction-free method can shorten the testing process and eliminate concerns over possible extraction reagent and consumable shortages. By incorporating Seegene’s proprietary high multiplex technology, Seegene becomes the first in the market to target both COVID-19 and variants with a single tube of reagent. The company already has over 150 multiplex diagnostic tests in its portfolio including HPV and STI assays. With the company’s big data auto-surveillance in silico system, the diagnostic firm said it closely monitors and analyzes global databases on the coronavirus and its variants, enabling swift response with further product development. Dr. Jong-Yoon Chun, CEO of Seegene said its new COVID-19 test will “help lessen the burden of the testing process as the turn-around-time for screening both COVID-19 and virus variants will drop to less than two hours after nucleic acid extraction.” Currently, health authorities have 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. Dr. Chun added its “variant diagnostic test will ultimately boost massive testing ability in its fight against COVID-19, coupled with more contagious mutant variants.” The need to screen COVID-19 variants has become an essential tool in effectively controlling infections and handling patient care, following worrisome developments that some COVID-19 vaccines produce a weakened immune response against the contagious virus variants. Seegene previously introduced ‘Allplex™ SARS-CoV-2 Variants Ⅰ Assay,’ a diagnostic test capable of identifying origins of multiple variants. This particular test can detect and differentiate virus variations that seem to have originated from the UK, South Africa, Japan and Brazil as well as additional suspicious variants. The two diagnostic assays can be complimentary in that it can screen COVID-19 as well as filter and identify the origins of virus variants, allowing health authorities to better trace the virus and handle patients. Dr. Chun added that “Seegene will continue to monitor the progress of virus variants and provide with more COVID-19 diagnostic tests to help contain the spread of COVID-19.” 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.
Mar 03, 2021View Detail >
A new study shows that the less-invasive saliva test for COVID-19 gives just as accurate results as those of the nasopharyngeal specimen. A research team at the Department of Laboratory Medicine at Kangwon National University School of Medicine, led by Professor In-bum Suh, carried out the PCR test for COVID-19 on 90 hospitalized individuals with suspected COVID-19, both with saliva and nasopharyngeal methods. In order to collect sufficient specimen, samples were collected from study participants, who were required to refrain from any activities including eating, drinking, and smoking, for 30 minutes after they got up in the morning. For the study, the research team had used Seegene's flagship COVID-19 tests, 'Allplex™ SARS-CoV-2 Assay' and 'Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay, both of which had been CE-IVD marked. While 'Allplex™ SARS-CoV-2 Assay' targets 4 different genes of COVID-19, 'Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay' is known to detect and differentiate 8 target genes including COVID-19, influenza and RSV common cold. As a result, both 'Allplex™ SARS-CoV-2 Assay' and 'Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay' proved the saliva and nasopharyngeal test's percentage agreement for detecting COVID-19 was over 98.8%. That means Seegene's COVID-19 diagnostic test gives equally accurate and effective test results for COVID-19 when testing saliva and nasopharyngeal specimen. Professor Suh, the lead researcher of the study said, "The demand for saliva-based COVID-19 tests is on the rise, as the world still battles with short supply of specimen collecting swab for nasopharyngeal tests." He added that the study has "clearly proven that saliva tests are just as accurate and effective as nasopharyngeal tests in precisely diagnosing COVID-19." The research team also conducted a separate study on extraction-free application, one without the nucleic acid extraction step, and found the percentage agreement between Seegene's extraction-free saliva test and extraction-free nasopharyngeal swab test to be over 96%. In other words, the extraction-free method using the saliva sampling would be just as applicable for the PCR test in detecting SARS-CoV-2. Generally in COVID-19 PCR tests, the nucleic acid extraction process is considered as a prerequisite in order to isolate and purify nucleic acid from specimens. Depending on the circumstances, however, some countries may not be fully equipped to carry out the extraction process. Some even face reagent shortages, despite a surge in testing capacity, eventually leading many laboratories to resort to extraction-free method. The implication of the study will be introduced during the 28th International Molecular Medicine Tri-Conference. The three-day conference will be held online due to COVID-19 pandemic starting February 16th. The Molecular Medicine Tri-Conference is one of the leading international meeting places for the precision medicine community, where leaders are invited to discuss the latest research and technologies in COVID-19 diagnostics and bio therapeutics.
Feb 16, 2021View Detail >
- 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, 2021View Detail >
South Korea’s leading molecular diagnostics firm Seegene Inc. (KQ096530) said Wednesday that it is expanding its business in Latin America in the new year with a strong focus on its multiplex assay product. Seegene said it received an approval from Brazil’s ANVISA, the National Health Surveillance Agency, in January for the use of its Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay, a syndromic test that can detect multiple target genes including COVID-19, influenza and common cold. Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay is a real-time RT PCR assay that can simultaneously screen and differentiate 8 targets, including Flu A, Flu B, RSV A/B and three target genes of COVID-19 (S gene, RdRP gene and N gene) along with two internal control targets in a single tube of reagent. The assay is known to accurately detect COVID-19 viruses, even with mutated strains, as it targets multiple coronavirus genes. Accurately distinguishing COVID-19 patients from those with seasonal flu virus has become extremely important, especially at a time when the coronavirus gained extra strength, coupled with a more contagious mutant COVID-19 strain. An official from Seegene said the multiplex assay will help the Southern Cone better prepare for the influenza season, which in Latin America usually begins in the second quarter. Seegene believes the official introduction of the COVID-19, influenza, common cold combo assay product in Latin America will definitely help drive up the sales revenue in that region. The Korean firm saw its sales revenue in the region pop up by more than 40-fold in just a year from KRW 4 billion in 2019 to KRW 161 billion in 2020, largely attributed by the growth in demand of its COVID-19 diagnostic tests. Also Seegene’s Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay won the fiercely competitive bidding process in Peru this year, enabling some 24 regions to proceed with the coronavirus / flu coinfection research project. Making inroads into the country, Seegene’s multiplex assay will be used for epidemiological investigation in the first quarter this year. An official from Seegene said the COVID-19 pandemic has laid the groundworks for molecular diagnostic testing in the region and that the company will continue to work with countries in Latin America to curb the spread of coronavirus.
Jan 21, 2021View Detail >
Apr 10, 2020View Detail >