QIAGEN announces worldwide shipments of QIAstat-Dx test kits for SARS-CoV-2
• QIAstat-Dx Respiratory 2019-nCoV Panel rapidly differentiates novel coronavirus from 21 other pathogens implicated in serious respiratory syndromes
• Panel being tested at four hospitals in China after initial evaluation on clinical samples by a leading Paris hospital
• Adds to QIAGEN’s portfolio of molecular testing solutions to aid in global public health emergency
Hilden, Germany, and Germantown, Maryland, February 26, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has shipped its newly developed QIAstat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China for evaluation. The new kit detects the novel coronavirus SARS-CoV-2 and adds rapid Sample to Insight syndromic testing to QIAGEN’s portfolio of molecular testing solutions in the public health emergency. QIAGEN is also in the process of shipping QIAstat-Dx testing kits to public health institutions in other regions, including Europe, South-East Asia, and the Middle East.
Since January QIAGEN has been providing instruments and consumables to support detection of the virus in China and other markets. Official protocols for SARS-CoV-2 detection include QIAGEN extraction kits, reagents and instruments for real-time polymerase chain reaction (RT-PCR) workflows. Customers also are deploying QIAsymphony modular instruments and NeuMoDx integrated PCR systems to automate higher-throughput processing of their laboratory-developed tests for SARS-CoV-2.
“Our dedicated task force has moved very fast to develop and make available the QIAstat-Dx respiratory panel with SARS-CoV-2 detection. We are partnering closely with authorities and customers around the world to bring rapid, accurate diagnosis to the fight against this deadly infectious disease,” said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. “As we have in past health crises such as SARS and the swine flu, QIAGEN is working hard to deliver better, faster testing solutions for hospitals and public health institutions to aid in the effort to monitor and bring the outbreak under control. Our employees’ extraordinary response embodies QIAGEN’s core mission to make improvements in life possible.”
The QIAstat-Dx system was introduced in Europe in 2018 as a CE-product and cleared by the Food and Drug Administration (FDA) in the United States in mid-2019. It enables fast, cost-effective and easy-to-use syndromic testing with novel Sample to Insight workflows. The system streamlines molecular testing from end to end. 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.
New QIAstat-Dx testing solution for SARS-CoV-2
The QIAstat-Dx Respiratory 2019-nCoV Panel is a new version of the existing QIAstat-Dx Respiratory Panel for differential analysis of 21 viral and bacterial pathogens in respiratory syndromes. Once the SARS-CoV-2 genome was sequenced in January, QIAGEN developed two highly sensitive assays to detect SARS-CoV-2 targeting ORF1b and the E gene. The addition of these targets provides parallel tools for combined detection of the novel coronavirus with increased sensitivity.
The expanded QIAstat-Dx panel is currently being evaluated at the Bichat-Claude Bernard Hospital in Paris. “After more than a year of experience using the existing QIAstat-Dx Respiratory Panel to evaluate patients coming into our Emergency Department with respiratory syndromes, we are evaluating the new panel with SARS-CoV-2 against RT-PCR testing using WHO recommended protocols. The QIAstat-Dx solution can provide results in about one hour, with high sensitivity and specificity and minimal hands-on time for hospital or laboratory personnel,” said Dr. Benoit Visseaux, Associate Professor of Virology at Bichat-Claude Bernard Hospital in Paris.
Amid the rapidly evolving response to the coronavirus outbreak, the regulatory status of the QIAstat-Dx Respiratory Panel will vary by location. QIAGEN will apply for emergency authorization for marketing of the new panel from the U.S., the Korean KCDC/MFDS, and FDA and China’s National Medical Products Administration (NMPA); the panel will be available with CE-IVD marking in Europe and other markets.
Multiple other QIAGEN testing solutions for SARS-CoV-2
QIAGEN has moved quickly on several fronts to provide molecular testing solutions to researchers working to counter the international threat from the SARS-CoV-2 virus. Building on its strong position and experience in molecular testing for infectious diseases, QIAGEN is providing a variety of solutions:
- Enabling laboratory-developed tests (LDTs) – extraction kits, PCR enzymes and instruments, supporting in-house testing by laboratories and public health institutions. CDC guidelines for RT-PCR testing list QIAGEN’s EZ1 DSP Virus kits, which run on EZ1 Advanced workstations, and QIAamp DSP Viral RNA Mini kits, which can be automated on QIAcube instruments. Chinese authorities and the Berlin Charitè protocol also include QIAGEN consumables.
- Mid- and high-throughput automation – QIAsymphony modular systems for sample preparation and PCR analysis, as well as NeuMoDx 96 and 288 systems for fully integrated PCR analysis, enabling customers to implement higher-throughput solutions for laboratory-developed RT-PCR tests. QIAGEN recently started placing NeuMoDx systems in China, for use in with LDTs in SARS-CoV-2 testing.
- Additional real-time PCR tests – two new RT-PCR tests for detection of SARS-CoV-2 have been developed at QIAGEN sites in China and the United States and will be available for Research Use Only. The company is investigating potential emergency use options for the automated PCR-based test solutions.
Further information can be also 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, 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).