Germantown, Maryland, and Hilden, Germany, June 19, 2019 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced an agreement for McKesson Medical-Surgical Inc., an affiliate of McKesson Corporation , a global leader in healthcare supply chain management solutions, to serve as the exclusive distributor of QIAGEN’s QIAstat-Dx syndromic testing solution in the “acute” market segment of U.S. hospitals with 200 beds or less and in other select segments. The agreement also makes McKesson a non-exclusive distributor for future expansion of QIAstat-Dx into the non-acute retail clinics located in U.S. retail pharmacies.
The distribution relationship complements QIAGEN’s sales and marketing focus on the rapidly growing syndromic market in the larger hospitals and clinical laboratories setting, which QIAGEN has been serving with innovative and differentiated solutions for almost two decades. At the same time, the use of syndromic testing is expanding into smaller hospitals, physician offices and retail pharmacy-operated clinics.
The smaller-hospital segment alone is rapidly growing and currently includes one-third of the estimated 6,000 hospitals in the United States. It represents approximately 10% of the current U.S. market for syndromic testing, which is estimated at $650 million annually. U.S. hospitals in the acute market are estimated to run approximately 750 respiratory tests per year on average. QIAGEN estimates the total addressable market for respiratory and related syndromic testing in the acute segment at about 1.5 million tests per year in the United States.
The agreement with McKesson comes after the QIAstat-Dx syndromic testing system received 510(k) clearance from the U.S. Food and Drug Administration along with the multiplex QIAstat-Dx® Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens. This comprehensive respiratory panel detects more than 20 pathogens and is the first test in a deep and broad pipeline of assays planned for QIAstat-Dx in the U.S. that includes the addition of a comprehensive gastrointestinal panel later in 2019.
“We are very pleased to partner with McKesson, the largest healthcare distributor in the U.S., to bring QIAstat-Dx and its rapid, cost-effective syndromic insights as quickly and efficiently as possible to physicians and their patients in smaller hospitals across the country,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “McKesson has a very powerful commercial reach, strong relationships and experience in both the acute segment of smaller U.S. hospitals and the non-acute setting in retail clinics. We believe that working with McKesson will accelerate placements for QIAstat-Dx among U.S. customers for syndromic testing as we can cover segments that have previously not been in focus for our teams. We look forward to a productive relationship with McKesson and together meeting the important and growing need to help patients gain insights into syndromic conditions.”
McKesson has extensive experience in delivering molecular diagnostics and other advanced infectious disease solutions. Through its Laboratory Solutions business, McKesson has represented manufacturers on an exclusive basis in the community hospital as well as the non-acute markets. After an exhaustive evaluation process, McKesson determined QIAGEN’s new QIAstat-Dx platform was an ideal multiplex/syndromic solution for its customers.
“We are excited to begin this partnership with QIAGEN,” says Doug Shaver, Senior Vice President and General Manager of McKesson Laboratory Solutions. “QIAGEN has a proven track record of delivering innovative diagnostic solutions around the globe. QIAGEN’s mission of providing differentiating Sample to Insight solutions matches up exceptionally well with McKesson’s vision to improve care in every setting – one product, one partner, and one patient at a time.”
Demand for syndromic testing with molecular diagnostics in the U.S. is growing rapidly, to accurately evaluate infections and other diseases that manifest as a set of symptoms with uncertain causes. According to the U.S. Centers for Disease Control (CDC), as many as 35 million cases of influenza each year lead to several hundred thousand hospitalizations and as many as 56,000 deaths in the U.S. The CDC uses estimates of flu cases because most respiratory infections are not diagnosed or reported with precision as part of the agency’s disease surveillance system.
QIAstat-Dx significantly improves syndromic testing workflows for customers:
- Powerful sample and assay technologies – QIAGEN sample and assay technologies have the potential to deliver true Sample to Insight evaluation from almost every sample and deliver accurate measurement with advanced real-time PCR (polymerase chain reaction) assay technologies.
- Ease of use – A lab technician loads a clinical sample into a single-use QIAstat-Dx cartridge and places it in the analyzer, requiring less than one minute of hands-on time. Sample processing is built in, all reagents are on-board, and the technician’s workflow is intuitive.
- Speed – QIAstat-Dx is designed to operate in a range of near-patient clinical settings, eliminating the delay of sending samples to a centralized laboratory. Results are available in about one hour.
- Superior benefit/cost ratio – QIAstat-Dx apply advanced microfluidic technologies which allow manufacturability and scaling significantly superior to other systems, bringing efficiency and effectiveness benefits to healthcare providers which contribute to the challenges faced in the current reimbursement landscape. Connectivity and bi-directional integration into laboratory information systems add further efficiencies.
- Flexibility – Cartridges are processed in a scalable, proprietary and fully integrated platform that can be configured from one to four modules, depending on the volume needed.
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 March 31, 2019, QIAGEN employed approximately 5,100 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).