Seegene Announces Submission to U.S. FDA for Emergency Use Authorization of Its AllplexTM SARS-CoV-2/FluA/FluB/RSV Assay

Real-time test differentiates influenza A & B, RSV and COVID-19

SEOUL, South Korea–(BUSINESS WIRE)–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 eight 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 Seegene’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 help address 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 Testing

Widescale 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.

Contacts

Seegene, Inc.
Ashlee Semin Shin

P: +82-2-2240-0685

E: smshin@seegene.com

U.S. Media Contact:

Kristin Schaeffer

P: +1 814-360-0660

E: kschaeffer@cglife.com