QIAGEN has announced it has entered into an agreement to acquire STAT-Dx, a privately-held company developing the 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, to be branded as QIAstat-Dx subject to closing of the transaction that is planned for the second quarter of 2018, enables scalable Sample to Insight processing of up to 48 molecular targets simultaneously to diagnose 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 in about one hour into the precise cause of various syndromes. QIAGEN believes this proprietary system has the capabilities to help drive greater dissemination of molecular testing.

Based on the proprietary DiagCORE® technology, the system was unveiled in April 2017 at the European Congress of Clinical Microbiology (ECCMID) and received a first CE-IVD marking in January 2018. The first two tests, which are extensive respiratory and gastrointestinal panels, are to be launched in Europe in the second half of 2018, in the U.S. in 2019 following regulatory clearance, and in other markets worldwide pursuant to the respective regulatory timelines. Additional tests are in development that span infectious diseases, immune response monitoring, oncology and companion diagnostics.

The system has many key advantages:
• 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 samples or difficult-to-handle sputum samples in infectious disease with direct onboard swab processing.
• Flexible approach to result customization: The proprietary workflow design enables laboratories to take a tailored approach to the selective analysis and reporting of tested molecular targets. The flexible approach represents 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.
• Highly cost-efficient system: The system’s assay cartridges have significantly lower manufacturing costs compared to other systems. This more economical system should enable broader utilization – a significant benefit in the dynamically changing reimbursement landscape in the U.S. and other markets. Connectivity and seamless bi-directional integration into laboratory information systems (LIS) add further efficiencies and reduce system management costs.
• 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.

“QIAstat-Dx represents the next generation of innovation for multiplex syndromic testing, using powerful QIAGEN sample 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.

The system utilizes cost-efficient, single-use cartridges with built-in sample processing and all reagents on board. The cartridges are loaded with high-quality QIAGEN sample and assay technologies developed under a long-standing collaboration between the companies. 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 immuno-assays.

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 panels 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.

Subject to the successful completion of defined development activities by STAT-Dx, QIAGEN has agreed to acquire all shares of STAT-Dx for approximately $147 million in cash and additional payments of up to about $44 million based on the achievement of regulatory and commercial milestones. The acquisition is expected to be completed in the second quarter of 2018 and funded from existing cash reserves. For 2018, sales of about $7 million are expected from the QIAstat-Dx launch in Europe and other markets, while sales of at least $30 million are expected in 2019. Due to investments for commercialization, U.S. regulatory clearance and test development, the transaction is expected to be dilutive to full-year 2018 adjusted EPS by about $0.05 per share, but to be neutral in 2019.