QIAGEN launches QIAstat-Dx test kit for detection of SARS-CoV-2 coronavirus in Germany following derogation by BfArM
• First syndromic testing solution to obtain derogation in Germany as an in vitro diagnostic for the detection of SARS-CoV-2 , now available for purchase
• QIAstat-Dx Respiratory SARS-CoV-2 Panel deployed in pandemic can differentiate novel coronavirus from 21 other serious respiratory infections with one sample and delivers results in about one hour
• Adds an important tool for clinicians as part of QIAGEN’s global mobilization to scale up testing supplies for the COVID-19 response
Germantown, Maryland, and Hilden, Germany, March 18, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has obtained derogation in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic (“IVD”) for the detection of SARS-CoV-2. At the same time, the company announced that the panel has received CE marking for Europe-wide sale as an in vitro diagnostic (IVD) test to detect SARS-CoV-2.
As the first syndromic testing solution cleared for use in the coronavirus epidemic, the QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients who may have similar symptoms in a single testing run of about an hour.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The newly approved panel includes assays targeting two genes used to detect the pathogen behind the disease, Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2).
“We are pleased to launch the QIAstat-Dx SARS-CoV-2 test kits in Germany for clinical laboratories. QIAGEN is partnering with customers and public health authorities worldwide to provide a wide range of testing workflows, and the QIAstat-Dx syndromic panel adds an important tool for clinicians,” said Thierry Bernard, Interim CEO and Senior Vice President, Head of the Molecular Diagnostics Business at QIAGEN. “Our QIAGEN teams have responded rapidly to the spread of COVID-19 disease, implementing 24/7 production of test components, adding staff and investing in expanding production capacity. In addition to QIAstat-Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands that have been recommended in current testing guidelines worldwide, as well as numerous components and instruments for use in fighting this public health crisis.”
QIAGEN began shipping QIAstat-Dx test kits to various markets in February 2020 for clinical evaluation and has dramatically ramped up production of the respiratory panels. The kits run on QIAstat-Dx Analyzer, QIAGEN’s Sample to Insight syndromic tests system that automates molecular analysis to deliver differential detection in about one hour. QIAGEN has placed approximately more than 1,000 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories.
The automation system 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 DNA and RNA sample processing and analysis are built in, and the QIAstat-Dx instrument delivers results in about one hour.
In addition to SARS-CoV-2, the panel detects the following pathogens and subtypes of respiratory infections: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bocavirus, Bordetella pertussis, Legionella pneumophila and Mycoplasma pneumoniae.
A video on QIAstat-Dx can be found here
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 December 31, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found athttp://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, approvals and clearances, collaborations, markets, strategy, taxes or operating 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 and maintain regulatory approval of our products; the COVID-19 disease and any resulting or related disruptions to our business; 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).