QIAGEN Enters into Agreement to Acquire STAT-Dx

QIAGEN N.V. (The Netherlands) has entered into an agreement to acquire STAT-Dx (Barcelona, Spain), a privately-held company which develops next generation of multiplex diagnostics for one-step, fully integrated molecular analysis of common syndromes using a novel system based on real-time PCR technology and proven QIAGEN chemistries.

The system, which will be branded as QIAstat-Dx, enables scalable Sample to Insight processing of up to 48 molecular targets simultaneously for diagnosing syndromes, such as serious respiratory or gastrointestinal infections, as well as for use in oncology. With cost-efficient, easy-to-use assays suitable for any clinical sample type, the system can provide qualitative as well as quantitative insights into the precise cause of various syndromes in about one hour.

Based on the proprietary DiagCORE technology, the system received a first CE-IVD marking in January 2018. The system utilizes cost-efficient, single-use cartridges with built-in sample processing and all reagents on board. The cartridges are loaded with QIAGEN sample and assay technologies and a lab technician only needs to load a clinical sample into a cartridge and place it in the analyzer, requiring less than one minute of hands-on time.

The flexible modular system, which has bi-directional LIS (laboratory information system) interface capabilities, is designed to operate in a range of near-patient clinical settings, eliminating the delay of sending samples to a centralized laboratory. The cartridges are processed in a scalable, proprietary and fully integrated platform, which can be configured from one to eight modules, independently running cartridges with predefined assay protocols and managed via a touchscreen that offers simple step-by-step directions.

QIAstat-Dx is planned to be further developed with the aim of becoming the first analyzer that combines capabilities to run the highest multiplexing molecular diagnostic assays with the ability to quantitate and also process immunoassays. The first two tests, which are extensive respiratory and gastrointestinal (GI) panels, are to be launched in Europe in the second half of 2018, in the US in 2019 following regulatory clearance, and in other markets worldwide. Additional tests are under development for infectious diseases, immune response monitoring, oncology and companion diagnostics.

“QIAstat-Dx represents the next generation of innovation for multiplex syndromic testing, using powerful QIAGEN technologies and a real-time PCR technology that will allow for a much broader range of applications and drive the dissemination of molecular testing. The system is designed for significantly more cost-efficient test processing as required by the current reimbursement environment. Additional application areas for this system include companion diagnostics, quantitative analysis and immunoassay tests, offering customers a new level of flexibility and accurate diagnosis designed to support better outcomes for patients and healthcare systems,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “We look forward to adding QIAstat-Dx to our portfolio of Sample to Insight solutions. This is further confirmation as to how we are leveraging our advantages in sample and assay technologies, our leadership in providing solutions for infectious disease testing and the global reach of our commercial teams.”

“We are excited about accelerating the commercialization of our technology to bring fast, cost-effective syndromic testing closer to care for patients and healthcare providers. At the closing of the transaction, we will build on the achievements of our fantastic team in developing a best-in-class system and leverage QIAGEN’s resources with extensive R&D and commercial reach around the world,” said Jordi Carrera, co-founder and Chief Executive Officer of STAT-Dx.