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QIAGEN releases QIAstat-Dx test kit to the U.S. as first syndromic test for detection of SARS-CoV-2 coronavirus under new FDA PolicyGermantown, Maryland / Hilden, Germany, )
• QIAstat-Dx syndromic testing system can differentiate novel coronavirus from 20 other respiratory targets
• Requires less than one minute for sample preparation and delivers results in about one hour
• Adds an important tool for clinicians as part of QIAGEN’s global mobilization to dramatically scale up production of testing supplies for global response to COVID-19 pandemic
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has begun shipments to the United States of its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test to aid in diagnosing patients infected with the novel COVID-19 coronavirus under a new Policy of the U.S. Food and Drug Administration (FDA) announced on March 16. QIAGEN will submit this week the related Emergency Use Authorization (EUA) to the FDA.
The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 20 other respiratory infections in patients who may have similar symptoms in a single testing run of about one hour. It is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. This new panel includes assays targeting two genes used to detect SARS-CoV-2, the pathogen behind the disease.
“We are pleased to begin making QIAstat-Dx SARS-CoV-2 test kits available in the United States as the first syndromic test not only to detect SARS-CoV-2, but also a range of more than 20 other respiratory targets. This is an important step in our commitment to offer a range of solutions to support the public health fight against COVID-19 and dramatically ramp up production,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “Our teams have responded rapidly to the challenge, 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 to the U.S. and other countries around the world, and are committed to accelerating these efforts.”
The release of this new QIAstat-Dx test also comes after it was announced on March 13, 2020, that QIAGEN receive funding for this project in part from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No 75A50120C00014.
QIAGEN began shipping QIAstat-Dx SARS-CoV-2 test kits to other countries in February 2020 for clinical validation and has dramatically ramped up production of the respiratory panels. The kits run on QIAstat-Dx instruments, QIAGEN’s Sample to Insight syndromic system that automates molecular analysis to deliver differential diagnosis in about one hour. QIAGEN has placed more than 1,100 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories, including over 200 in the U.S. since FDA clearance of the QIAstat-Dx Analyzer was granted in May 2019.
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 into the instrument, and the QIAstat-Dx instrument delivers results in about one hour.
In the evolving global response to the coronavirus outbreak, the regulatory status of the QIAstat-Dx Respiratory SARS-CoV-2 Panel will vary by location.
In addition, 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, Bordetella pertussis, Chlamydophila pneumoniae 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.
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, the duration of any such approvals or clearances, development or regulatory support from governmental agencies, 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 duration of the U.S. government’s declaration of emergency relating to COVID-19; the extent of development or regulatory support that we receive; 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).
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