QIAstat-Dx system (formerly Stat-Dx DiagCORE)

	Status	2018-04-19 sales start
	Organisation	Qiagen GmbH
	Group	Qiagen (Group)
	Organisation 2	STAT-Diagnostica & Innovation S.L. (STAT-Dx)
	Group	Qiagen (Group)

Qiagen N.V.. (4/19/18). "Press Release: Qiagen Announces European Launch of QIAstat-Dx, a Next Generation Platform for Syndromic Insights". Hilden & Germantown, MD.

Posters by early adopters demonstrate accurate, fast, cost-effective and flexible diagnosis of syndromic infections and other diseases in unique and versatile Sample to Insight workflows

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of QIAstat-Dx in Europe, providing a one-step, fully integrated molecular analysis of common syndromes as tested for in syndromes in infections, oncology and other diseases. The launch follows the closing of the acquisition of Stat-Dx announced in January 2018 and the successful completion of defined development activities by Stat-Dx. Further details of the transaction were not disclosed.

QIAstat-Dx (formerly Stat-Dx DiagCORE) represents the next-generation in multiplex molecular diagnostic systems that enables fast, cost-effective and flexible syndromic testing with novel Sample to Insight solutions powered by QIAGEN chemistries. The system, based on the proprietary DiagCORE technology, received CE-IVD marking in January 2018 and already has a significant installed base among early adopters. QIAstat-Dx is now being launched with an upgraded CE-IVD-marked respiratory panel that detects 21 pathogens. The panel is the first test in a deep and broad pipeline of planned assays for QIAstat-Dx which spans infectious diseases, oncology, companion diagnostics and other disease areas.

“We are pleased to launch QIAstat-Dx and are excited about its features and capabilities which position it as the next generation of innovation for multiplex syndromic testing,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “We are today launching in Europe and expect to have launched QIAstat-Dx system in most countries worldwide by the first half of 2019, including in the United States, and subject to regulatory clearances. A very promising pipeline of future applications and assays will add exciting value to our customers, including capabilities and assays in companion diagnostics and oncology, as well as in quantitative analysis and immunoassay testing.”

The system’s key advantages include:

> Powerful technology capabilities: Using powerful QIAGEN sample and assay technologies, the system can deliver true Sample to Insight processing of even the most challenging samples, opening up opportunities in a broad range of application areas not possible with currently available systems. Samples include tissue samples in pathology, liquid or difficult-to-handle sputum samples in infectious disease, with direct onboard swab processing.

> Multi-analyte capabilities: The system is the only multiplex syndromic testing system based on real-time PCR (polymerase chain reaction) technology that can process up to 48 targets, and is designed with the additional capability to process immuno-assays. These features create unmatched target and application versatility, as well as disease management options.

> Integration of real-time PCR technology: This system enables customers to precisely quantify biological targets, which is specifically important in oncology or transplantation patients and leads to improved treatment decisions. The use of real-time PCR also allows a vast portfolio of current real-time PCR tests to be portable onto the system.

> Flexible approach to results: The proprietary workflow design with an attractive cost of ownership has the potential to enable laboratories to take a tailored approach to the selective analysis and reporting of tested molecular targets. The flexible approach will represent a significant improvement over currently available systems that offer rigid panel designs, and therefore require co-processing of molecular targets found to be irrelevant in the patient sample, which may complicate reimbursement.

QIAGEN will host an educational event on Monday, April 23, at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Madrid, Spain, and will provide system demonstrations during the conference. Experts from QIAGEN’s network of early adopters will report on their experiences with the system, which was first unveiled at ECCMID in April 2017.

At this year’s ECCMID, five scientific studies demonstrating the sensitivity, ease of use and features of the QIAstat-Dx applications will be presented in posters:

> One study concludes that clinical prevalent and relevant respiratory pathogens including all strains, genotypes and subtype strains can be successfully detected by the DiagCORE Respiratory Panel. (Abstract P0583: Assessing DiagCORE Respiratory Panel Specificity in detecting respiratory tract infections).

> Other data shows that all relevant gastrointestinal pathogen strains intended to be detected with the DiagCORE Gastrointestinal Panel were represented in an inclusivity test, with inclusivity rates ranging from 94.7-100% of total target sequences for all pathogens. (Abstract P0441: Who’s in and who’s out. Specificity of the DiagCOREGastrointestinal Panel Assessing DiagCORE Respiratory Panel Specificity in detecting respiratory tract infections).

> Abstract P0432 (DiagCORE Gastrointestinal Panel: a sensitive real time RT-qPCR based approach to syndromic testing) investigated the sensitivity of the Gastrointestinal Panel and presents data that shows a “high level of sensitivity” and “excellent reliability without the need for sample preparation steps.”

> Research on the “Evaluation of the performance of direct nasopharyngeal swabs for Acute Respiratory Syndrome molecular diagnostics by the highly multiplex STAT-Dx Respiratory System” (Abstract P0553) found a high sensitivity rate of 98,4% for testing direct swaps with the DiagCORE Respiratory panel, creating a unique ability which “will support safe testing practices in both the laboratory and the point-of care-setting.”

> The authors of Abstract E0100 (“Evaluation of the performance of direct stool and rectal swabs for molecular diagnostics of infective gastroenteritis by the highly multiplexed Stat-Dx gastrointestinal system” finally concluded that “the combination of rapid sample acquisition, such as rectal swabs, with sensitive rapid detection methods, such as PCR, may allow for targeted treatment and [has] the potential for signi?cantly improved outcomes for this common and, in many places, deadly infection.”

More information on QIAstat-Dx can be found at http://QIAstat-Dx.com. For additional information on QIAGEN’s presence at ECCMID please go to: http://eccmid2018.qiagen.com

The demand for syndromic testing with molecular diagnostics is growing rapidly. In respiratory syndromes and flu testing, QIAGEN estimates the total addressable market at about 1.5 million tests per year in the United States and 1.1 million in Europe. In GI syndromes, the number of cultures and other methods currently being run is estimated at 2.6 million per year in the United States and about two million in Europe, with a relatively small but fast-growing number of those tests using molecular diagnostics.

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), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2017, QIAGEN employed approximately 4,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

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).