Hilden, Germany, and Germantown, Maryland, November 11, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) has started commercialization of a portable digital test in the United States that can be used by laboratories to detect SARS-CoV-2 antigens in people with active infections in 2-15 minutes. A point of care (POC) claim will be added and EUA amended later this year.
The QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, sets new standards in scalability, validation and flexibility by processing more than 30 swab samples per hour, providing digital test results that do not require subjective interpretation, and allowing antibody tests to run simultaneously with antigen tests. This flexibility will be particularly valuable when vaccines are introduced.
QIAGEN has begun marketing and distributing QIAreach™ SARS-CoV-2 Antigen Test in the United States after applying for FDA emergency use authorization (EUA) for symptomatic patients. CE-IVD registration for European Union and other markets is expected as early as by the end of the year.
“As existing approaches often lack scalability and accuracy, antigen testing is playing an increasingly important role in national testing strategies as a complementary tool to PCR, the gold-standard for detecting active COVID-19 infections,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “QIAreach SARS-CoV Antigen is a fast, digital and easy to use test that makes use of sensitive nanoparticle technology from Ellume. In as little as two minutes it allows objective reading of test results that provide clear qualitative interpretation. And it addresses the growing need for higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub simultaneously.”
Testing of clinical samples have shown the QIAreach™ SARS-CoV-2 Antigen Test to have a sensitivity of 90% and a specificity of 100%. It is the second QIAGEN COVID-19 test to make use of the digital eHub and eStick system made by its partner Ellume. QIAGEN in August announced the QIAreach™ Anti-SARS-CoV-2 Antibody Test – and both tests can run on the digital platform interchangeably.
The portable system provides a true walkaway solution with random access and does not require maintenance or calibration. It contains a rechargeable battery for eight hours of remote use and can fully connect to laboratory information management systems (LIMS) with an optional use software. The eHub will also run the QIAreach QuantiFERON®-TB test, a novel test for the detection of latent tuberculosis infections in low resource and high burden settings that is currently in development.
QIAreach™ SARS-CoV-2 Antigen Test uses the rugged and portable eHub to analyze eight eSticks with nasopharangeal-swab samples from symptomatic people at once, each test running independently of the others. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the inside of the virus. The device can detect strong positive cases in as little as two minutes and negative cases in 15 minutes.
For more information on QIAreach™ SARS-CoV-2 Antigen Test please visit https://go.qiagen.com/QIAreach-SARS-CoV2-Antigen-Test-LearnMore. Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Ellume is an Australian-based digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumers. Our focus is on the detection of common illnesses which affect the global population and our products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Ellume has developed novel detection technology powered by our unique quantum dot nanoparticle, which integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Further information can be found at www.ellumehealth.com
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).