Seegene Submits Allplex SARS-CoV-2/FluA/FluB/RSV Assay for US FDA Emergency Use Authorization
By HospiMedica International staff writers Posted on 04 Mar 2021 |
Image: Allplex SARS-CoV-2/FluA/FluB/RSV Assay (Photo courtesy of Seegene, Inc.)
Seegene, Inc. (Seoul, Korea) has submitted its Allplex SARS-CoV-2/FluA/FluB/RSV Assay to the US 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.
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. 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.”
“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 US to help address the continued demand."
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.
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. 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.”
“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 US to help address the continued demand."
Latest COVID-19 News
- Low-Cost System Detects SARS-CoV-2 Virus in Hospital Air Using High-Tech Bubbles
- World's First Inhalable COVID-19 Vaccine Approved in China
- COVID-19 Vaccine Patch Fights SARS-CoV-2 Variants Better than Needles
- Blood Viscosity Testing Can Predict Risk of Death in Hospitalized COVID-19 Patients
- ‘Covid Computer’ Uses AI to Detect COVID-19 from Chest CT Scans
- MRI Lung-Imaging Technique Shows Cause of Long-COVID Symptoms
- Chest CT Scans of COVID-19 Patients Could Help Distinguish Between SARS-CoV-2 Variants
- Specialized MRI Detects Lung Abnormalities in Non-Hospitalized Long COVID Patients
- AI Algorithm Identifies Hospitalized Patients at Highest Risk of Dying From COVID-19
- Sweat Sensor Detects Key Biomarkers That Provide Early Warning of COVID-19 and Flu
- Study Assesses Impact of COVID-19 on Ventilation/Perfusion Scintigraphy
- CT Imaging Study Finds Vaccination Reduces Risk of COVID-19 Associated Pulmonary Embolism
- Third Day in Hospital a ‘Tipping Point’ in Severity of COVID-19 Pneumonia
- Longer Interval Between COVID-19 Vaccines Generates Up to Nine Times as Many Antibodies
- AI Model for Monitoring COVID-19 Predicts Mortality Within First 30 Days of Admission
- AI Predicts COVID Prognosis at Near-Expert Level Based Off CT Scans