QIAGEN gains BARDA funding for approval process of QIAstat-Dx test kit for SARS-CoV-2 coronavirus 
mars 13 2020

QIAGEN gains BARDA funding for approval process of QIAstat-Dx test kit for SARS-CoV-2 coronavirus 

• First syndromic testing solution to get U.S. agency’s development support in novel coronavirus response
• QIAstat-Dx Respiratory SARS-CoV-2 Panel test kit will rapidly differentiate novel coronavirus from 21 other pathogens implicated in respiratory syndromes
• Further expanding QIAGEN’s global mobilization to scale up testing supplies for the COVID-19 response

Hilden, Germany, and Germantown, Maryland, March 13, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it will develop a new QIAstat-Dx test kit to differentiate the novel SARS-CoV-2 coronavirus from 21 other serious respiratory infections and will receive advanced development support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR). Accelerated development of the QIAstat-Dx test kit further expands QIAGEN’s global mobilization for the emergency, which already includes a dramatic increase in production of components for a full range of U.S. and international testing protocols.

QIAGEN’s QIAstat-Dx solution to help in the response to COVID-19 disease becomes the first syndromic testing product selected for development through ASPR's Biomedical Advanced Research and Development Authority (BARDA) streamlined selection process, known as an easy broad agency announcement (EZ-BAA). BARDA will contribute $598,000 to accelerate QIAGEN's evaluation of the testing cartridge that detects the genetic material of SARS-CoV-2, the virus that causes COVID-19.

The QIAstat-Dx kit will be a molecular testing panel designed to aid in the diagnosis of patients with respiratory syndromes, in about one hour, by differentiating the novel coronavirus from 21 other bacterial and viral respiratory pathogens. QIAGEN’s panel will include assays targeting two genes used to detect the pathogen behind the disease, Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2). The virus was provisionally called 2019-nCoV when it first surfaced.

“The coronavirus emergency goes to the heart of QIAGEN’s mission and expertise. Our team is partnering with customers and public health authorities worldwide to quickly scale up capacity for coronavirus testing, and also to make available the Sample to Insight QIAstat-Dx respiratory panel with SARS-CoV-2 detection,” said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. “We have scaled up production to respond to the rapid spread of COVID-19, moving to 24-hour, seven-day-a-week operations at two key sites, investing to expand capacity by 70% and adding staff. Our top priority is producing the QIAamp and EZ1 sample technologies recommended in the U.S. Centers for Disease Control guidelines for testing, as well as the new QIAstat-Dx cartridges. We are working closely with laboratories, hospitals and other customers around the world to assess their flexibility, timing and quantity needs.”

QIAGEN is aggressively managing supply chains and customer service to help address the pandemic. The company has worked with customers to help support laboratory-developed tests, including applications for QIAGEN automation systems. Unlike other companies, QIAGEN is not facing supply chain interruptions from China or other markets. For customers facing delays or allocations, QIAGEN is working out individualized supply plans and alternative workflow solutions.

The HHS funding and QIAGEN’s discussions with the U.S. Food and Drug Administration (FDA) are the first steps to adding the QIAstat-Dx syndromic testing solution to U.S. efforts to contain the outbreak.

In the rapidly evolving global response to the coronavirus outbreak, the regulatory status of the QIAstat-Dx Respiratory SARS-CoV-2 Panel will vary by location. The panel will be available with CE-IVD marking in Europe and other markets in the coming weeks.

The QIAstat-Dx system was introduced in Europe in 2018 and in the United States in mid-2019. It enables fast, cost-effective and easy-to-use syndromic testing with Sample to Insight workflows. A technician simply loads a clinical sample (such as a swab) into a single-use QIAstat-Dx cartridge and places it in the analyzer. QIAGEN chemistries for sample processing and analysis are built in, and the QIAstat-Dx instrument delivers results in about one hour.

Further information on QIAGEN’s response to the coronavirus outbreak can be found here.

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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of December 31, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected net sales, net sales of particular products (including anticipated sales of its QuantiFERON latent TB Test, its portfolio of next generation sequencing solutions and QIAstat-Dx), adjusted net sales, adjusted diluted earnings per share results, product launches (including anticipated launches of digital PCR products, a new version of its QuantiFERON-TB test, QuantiFERON-TB Access, the QIAstat-Dx panel for respiratory conditions and a CE-IVD marked panel for meningitis), placements of QIAsymphony modular PCR instruments, improvements in operating and financial leverage, currency movements against the U.S. dollar, and plans for investment in its portfolio and share repurchase commitments, 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; 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 (SEC).

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