QIAGEN Announces European Launch of QIAstat-Dx
Product News Apr 22, 2018
QIAGEN N.V. 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.