GERMANTOWN, Maryland, and HILDEN, Germany, January 20 2021–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it plans to resubmit in the first quarter of 2021 its QIAreach SARS CoV-2 Antigen Test to the U.S. Food and Drug Administration for Emergency Use Authorization to detect SARS-CoV-2 antigens in people with active infections in 15 minutes.
This comes after QIAGEN decided to proactively withdraw the first submission made in November 2020 for this product to address a chemistry-related issue. QIAGEN believes it has resolved the issue, and data is now being collected for submission to the FDA. The eHub used to read out test results is not affected.
“We are working closely with the FDA to ensure that all necessary information is submitted as quickly as possible so that we can make this product available as a solution in the fight against the COVID-19 pandemic, as many U.S. customers have expressed significant interest in using QIAreach to expand their testing capacity,” said Thierry Bernard, Chief Executive Officer of QIAGEN.
QIAGEN launched the QIAreach SARS-CoV-2 Antigen test in November 2020. The QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, is designed to process 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.
QIAGEN does not expect this decision to have an impact on the outlook for full-year 2021 sales and adjusted earnings, as communicated in December 2020.
About QIAGEN
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), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2020, QIAGEN employed approximately 5,300 people in over 35 locations worldwide.
QIAGEN Forward-Looking Statement
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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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.