QIAGEN to launch easy-to-use digital test in the U.S. for rapid detection of SARS-CoV-2 antibodies following FDA emergency use authorization
• Access Anti-SARS-CoV-2 is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies (IgA, IgM, IgG)
• New test based on QIAGEN partner Ellume’s proprietary technology, addresses current test shortfalls in terms of automation and convenient read-out of results
• Digital eHub and eStick system provides rapid qualitative serological in-vitro detection of total antibodies to SARS-CoV-2 in plasma and serum
• U.S. launch set to start in late August 2020 after submission for FDA Emergency Use Authorization, European CE-IVD marking and commercialization start planned in coming weeks
Germantown, Maryland, and Hilden, Germany, August 24, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, an easy-to-use digital test done on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus, which is the case of COVID-19.
The launch of this antibody test, which was developed in partnership with the Australian digital diagnostics company Ellume, comes after the submission by QIAGEN of this unique antibody test to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). First shipments are planned for late August 2020. A CE-IVD marking for Europe and other markets is planned in the coming weeks.
The new serological test has been shown to have sensitivity of 100% (CI 88.43–100.00%) and specificity of 100% (CI 95.20–100.00%).
“Increased testing is the only way to gain visibility on the magnitude of the pandemic, which will ultimately lead to helping control it,” said Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN. “As a trusted partner in the fight against COVID-19, QIAGEN has now added the Access Anti-SARS-CoV-2 to our portfolio as a smart solution for antibody testing that provides results with confidence. This is a rugged and portable platform that requires no hardware, can process a wide range of tests and provides fast results. We look forward to working with Ellume to discover and develop additional tests for this platform.”
The test is performed on the eHub, a small portable digital device that provides reliable results in 10 minutes. Each eHub can handle up to eight patient samples simultaneously and can perform up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples. The same platform is being used for QuantiFERON-TB Access, a new solution in development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high TB disease burden.
Currently available rapid lateral flow antibody tests fall short when it comes to the automated and convenient read-out of results. Manual and visual result reporting, and potential pitfalls in read-out timing can lead of uncertain testing results. The Access Anti-SARS-CoV-2 eHub and digital eStick approach mitigates those risks, providing reliable results no matter when the results are read and also providing true walk-away capability to free up laboratory personnel.
Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection. Understanding more about COVID-19 immunity in a population could help societies return faster to normal daily routines by helping to inform and guide public health measures, such as contact tracing and individual measures under clinical guidance. Antibody testing could also become fundamental in supporting vaccine development as well as guiding, planning, and assessing future SARS-CoV-2 immunization programs.
Access Anti-SARS-CoV-2 will complement QIAGEN’s array of COVID-19 testing solutions with a cost-effective way to detect immune responses in people who have been exposed to the virus.
QIAGEN employees around the world are fully mobilized to address the urgent demand for testing solutions needed in the global response to the coronavirus pandemic. QIAGEN’s initiatives focus on building the most comprehensive portfolio of solutions for COVID-19 testing. These include production of viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections; QIAGEN is also providing universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus. QIAGEN is also scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests.
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 June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.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).