Hilden, Germany, and Germantown, Maryland, October 5, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to launch a novel straightforward approach to viral RNA epidemiology that will significantly simplify and accelerate PCR analysis and remove key testing bottlenecks for SARS-CoV-2 and other RNA viruses.
QIAGEN’s innovative QIAprep& Viral RNA UM Kit combines a liquid-based sample preparation step completed in only two minutes with real-time PCR detection in a streamlined workflow that can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing. The kit, which uses the most common transport media such as Universal Transport Media (UTMTM) as the starting material, includes both sample extraction components and optimized PCR reagents for only one procedure.
The streamlined workflow takes under one hour to deliver a result, compared to approximately three hours for standard extraction-based quantitative PCR processes and can handle up to 2,600 samples per eight-hour shift per cycler. As a result, labs can significantly accelerate the time to result and the frequency of viral testing. With only three small pipette tips needed per sample, the kit keeps plastic usage to a minimum, while providing significant cost savings by reducing reagent use and labor utilization.
Initial studies run by select public health research institutions have shown that the level of detection of the new QIAprep& Viral RNA UM Kit, when used with their assay, is similar to or better than regular PCR workflows, and that performance compares to standard public health protocols of the U.S. Centers of Disease Control (CDC), the World Health Organization (WHO) and others that use the gold standard for sample extraction.
“We are excited to launch the first integrated liquid-based sample preparation and amplification method for testing of viral RNA with any assay, including SARS-CoV-2,” said Dr. Thomas Schweins, Senior Vice President of the Life Sciences Business Area at QIAGEN. “Unlike other products, QIAprep& does not eliminate the sample preparation step at the expense of performance. Instead, it streamlines the gold standard in sample preparation set by QIAGEN to a process completed in under two minutes to enable an immediate, fast real-time PCR run on any cycler that delivers results in under one hour. We are planning to ramp up the production capacities later in 2020 to levels that ensure a guaranteed supply and address effectively the challenge of long PCR turnaround times that are slowing down the frequency of testing.”
The QIAprep& workflow is simple, swift and straightforward, consisting of only three steps: an aliquot is taken from a primary sample (nasopharyngeal, oropharyngeal or nasal swab) in transport media and added to a sample preparation buffer that is optimized to prepare the viral RNA template without degradation. This is next combined with the RT-qPCR reaction mix, which provides reliable and sensitive results for RNA viruses in UTM. The sample then undergoes a routine real-time PCR in a cycler using any assay. The output is finally interpreted, delivering a test result in under one hour from start to finish – including incubation and hands-on time.
“QIAprep& makes the most of our expertise in both sample preparation and PCR,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “PCR is the gold standard for detection of SARS-CoV-2 and other RNA viruses, and QIAprep& makes it faster – without compromising performance. The launch of this new product will complement our efforts to build the broadest portfolio of COVID-19 testing solutions that addresses the varying needs for clinical and research applications in the fight against the pandemic.”
QIAGEN has been adding PCR tests on the QIAstat-Dx and NeuMoDx systems that differentiate COVID-19 from other respiratory infections, delivering research gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus on any sequencer and scaling up production capacity for sample preparation kits and reagents sold to other companies for their own COVID-19 tests. QIAGEN is also developing novel easy-to-use solutions for antibody and antigen testing running on a portable device that provides highly accurate results in less than 15 minutes.
QIAGEN’s QIAprep& Viral RNA UM Kit will be available for research applications in mid-October.
For an overview of QIAGEN’s coronavirus testing solutions, please visit
www.qiagen.com/coronavirus
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 June 30, 2020, QIAGEN employed more than 5,200 people in over 35 locations worldwide. Further information can be found at 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, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings 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 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. 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).