- Goal to reach global capacity for RNA nucleic extraction workflows for over 10 million patient tests a month by end of June 2020 and to reach capacity for 20 million monthly patient tests by end of 2020
- Welcomes FDA and CDC expansion of QIAGEN kits and instruments that can be used for RNA nucleic extraction step in workflows used for detection of SARS-CoV-2 coronavirus
- Anticipates CE-IVD clearance in coming days for SARS-CoV-2 Panel test for use on QIAstat-Dx syndromic testing, while working with FDA to gain emergency use authorization for United States
QIAGEN has historically allocated global production capacity to manufacture RNA nucleic extraction reagents to supply about 1.5 million patient tests on a monthly basis. Now QIAGEN is ramping up production capacity for these reagents to support a level of more than 6.5 million patient tests a month by the end of April 2020 and over 10 million patient tests a month by the end of June 2020. A significant capacity expansion project is underway at sites in Europe and the United States to reach more than 20 million patient tests on a monthly basis by the end of 2020 to support the response to this global public health crisis.
QIAGEN also expects to receive CE-IVD marking in the coming days 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. Discussions are continuing with the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) authorization of this panel. QIAstat-Dx was the first syndromic testing platform selected for development through the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA) with a grant of $598,000 to support development activities.
“QIAGEN teams are working 24/7 to address the unprecedented demand for reagents that has emerged to enable testing for COVID-19 in terms of RNA extraction, as well as for production of tests for use on the QIAstat-Dx syndromic testing system,” said Thierry Bernard, Interim CEO and Senior Vice President, Head of the Molecular Diagnostics Business Area, at QIAGEN. “We continue to work with our customers around the world to assess their flexibility, timing and quantity needs to support shipping of RNA extraction reagents to the most critical areas. We are determined to help public health authorities and medical staff around the world respond quickly to those who are ill and prevent the spread of this disease.”
QIAGEN’s portfolio of RNA extraction solutions include kits that can be automated on the QIAsymphony SP platform, as well as the QIAcube and EZ1 Advanced XL instruments. In the United States, the FDA has designated various QIAGEN instruments and kits for RNA extraction: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#donothaveextractionplatform.
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, 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).
