Hilden, Germany, and Amsterdam, Netherlands, April 11, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced new data of the QIAstat-Dx Meningitis / Encephalitis panel. The panel is in late stage development and being prepared for CE-IVD commercialization in the second half of 2019 for use on the QIAstat-Dx multiplex syndromic testing system. The preliminary data demonstrates effective detection of the most prevalent central nervous system pathogens with high analytical sensitivity and specificity levels, including the discrimination of clinically relevant strains and subtypes.
This new test will expand the QIAGEN menu of diagnostic panels for syndromic testing, adding to CE-IVD marked DiagCORE tests for respiratory and gastrointestinal infections that were launched in 2018. The U.S. regulatory clearance of QIAstat-Dx is expected in mid-2019, and a deep menu of additional tests covering infectious diseases and other therapeutic areas is in development.
The planned QIAstat-Dx Meningitis / Encephalitis panel in Europe is designed to enable one-step, fully integrated molecular diagnosis of meningitis (inflammation of the membrane surrounding the brain and spinal cord) or encephalitis (inflammation of the brain itself) conditions. The QIAstat-Dx panel will provide actionable insights in about one hour, analyzing more than 20 pathogens that cause meningitis / encephalitis syndromes, including bacteria, viruses and yeast and provides information on Ct values as well as amplification curves – some of the many features QIAstat-Dx boasts that no other syndromic system can offer.
“Our new QIAstat-Dx panel meets an urgent need for rapid and reliable diagnosis of meningitis and encephalitis infections, and will enable clinicians to select appropriate therapies in a timely manner. The panel delivers valuable insights with high sensitivity and specificity to identify these life-threatening syndromes,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “Laboratories in Europe are embracing the new platform and the power of syndromic testing based on proven PCR technologies to identify syndromic conditions with the simplicity of a true Sample to Insight solution. Demand for syndromic testing is growing rapidly, and we are developing a deep menu of assays to significantly increase the utility of QIAstat-Dx for an increasing range of applications.”
The data presented at the 29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2019), taking place April 13-16 in Amsterdam, Netherlands, showed the QIAstat-Dx Meningitis / Encephalitis panel offered combined automated sample preparation, amplification, detection and analysis in one step for molecular analysis of more than 20 pathogens. These included targets for Neisseria meningitidis (meningococcal strains including serotypes A, B, C, D, W, X, Y), Streptococcus pneumoniae, Streptococcus agalactiae (Group B Streptococcus), Listeria monocytogenes and all relevant Haemophilus influenzae subtypes.
An estimated 2.8 million cases of meningitis occurred globally in 2016, the most recent year for which data are available, according to a World Health Organization (WHO) report in February 2019. While deaths due to meningitis have declined in recent years, the disease still took an estimated 290,000 lives in 2015. Among survivors, meningitis can lead to brain damage, hearing loss or other permanent disabilities.
The QIAstat-Dx system’s key advantages include:
- Powerful technology capabilities: Using 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. The value of Ct values is currently in validation.
- 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.
For more information, please visit http://www.qiagen.com/ie/shop/detection-solutions/qiastat-dx.
QIAGEN at ECCMID 2019
Initial data on the QIAstat-Dx Meningitis Panel is presented at the conference, as well as over 30 other abstracts and presentations featuring QIAGEN products. For QIAstat-Dx alone, several highlights include:
- Specificity analysis of the new QIAstat-Dx meningitis/encephalitis panel focused on the most prevalent central nervous system pathogens – #P1549
- Evaluation of the QIAstat-Dx system for the detection of enteric pathogens – #P1531
- External control samples for verification of the QIAstat-Dx Respiratory Panel in the clinical care setting – #P1557
Exhibition booth No. 1.20 at ECCMID will feature demonstrations of QIAGEN’s Sample to Insight solutions for infectious diseases, including workflow for the QIAstat-Dx, NeuMoDx 288 and 96, and QIAsymphony automation systems. To learn more about QIAGEN’s presence at ECCMID, please visit http://eccmid.qiagen.com or follow the Twitter handle @QIAGEN during the conference.
Additionally, QIAGEN will host a symposium, “Diagnosis is in the details – how to improve patient outcomes in multiple clinical settings with rapid, easy-to-use syndromic testing utilizing real-time PCR and Ct values.,” at 4:00 p.m. Monday April 15 in Hall M – Forum Auditorium. Speakers include Dr. Glen Hansen of the University of Minnesota, Dr. Jordi Vila of Barcelona Hospital, Dr. Carmen Muñoz-Almagro of Barcelona Hospital Sant Joan de Déu, and Tanja Rockenbach of London’s Great Ormond Street Hospital for Children.
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, 2018, QIAGEN employed about 5,000 people in over 35 locations worldwide. Further information can be found at http://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 sales, adjusted net sales and adjusted diluted earnings per share 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; 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).