Multiplex molecular diagnostic platform
Qiagen has announced the launch of QIAstat-Dx in Europe, providing a one-step, fully integrated molecular analysis of common syndromes as tested for 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.
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. 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. 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 immunoassays. These features create superior target and application versatility, as well as disease management options. 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 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.