Sample-to-insight pathogen testing improves

QIAGEN has completed the acquisition of STAT-Dx and has launched QIAstat-Dx in Europe, initially with a CE-IVD-marked respiratory panel able to detect up to 21 pathogens. But the respiratory panel is just the first test in a deep and broad pipeline of planned assays for QIAstat-Dx, which spans infectious diseases, oncology and other disease areas and also has companion diagnostics potential. Final testing is also underway for a gastrointestinal panel able to test 27 pathogens, which reportedly has been proved effective by early adopters.

“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, CEO of QIAGEN. “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, 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 has been tested by a number of scientists in Europe, who have all reported positive results at the 2018 ECCMID conference in Spain. The authors of Abstract E0100 presented at the conference (“Evaluation of the performance of direct stool and rectal swabs for molecular diagnostics of infective gastroenteritis by the highly multiplexed Stat-Dx gastrointestinal system”) concluded that “the combination of rapid sample acquisition, such as rectal swabs, with sensitive rapid detection methods, such as PCR, may allow for targeted treatment and [has] the potential for significantly improved outcomes for this common and, in many places, deadly infection.”

QIAstat-Dx is a cartridge-based, qualitative multiplex molecular test assay, configured for use with an analyzer that tests for the presence or absence of of viral or bacterial pathogens. Sample preparation is said to be remarkably simple, using an easy direct swab, eliminating the need for extra sample preparations steps, and results are delivered in under a minute. The cartridge system has lower manufacturing costs than many other systems on the market and can analyze multiple pathogens simultaneously, cutting costs and eliminating the need for co-processing. The system also offers connectivity and bi-directional integration into laboratory information systems, further reducing system costs and increasing efficiency.

“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,” asserts Schatz.

QIAGEN and STAT-Dx had a long history of collaboration before the acquisition, with QIAGEN providing the sample and assay technologies which are loaded into the cartridges. Following STAT-Dx’s release of the DiagCORE system in April, 2017, they knew they needed a significant financial investment to develop the specific panels, as well as QIAGEN’s expanded capacity for quality control.

“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 CEO of STAT-Dx in January when the agreement was announced.

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 gastrointestinal syndromes, the number of panels currently being run is estimated at 2.6 million per year in the United States and about 2 million in Europe, with a relatively small but fast-growing number of those tests using molecular diagnostics.

Says Thierry Bernard, QIAGEN’s senior vice president of molecular diagnostics, “QIAStat-Dx is a really next-generation system. Right now, we are teaching 120 people each day to use the system—it will move molecular diagnostics forward. We can eventually use it for drug discovery, and it will have a positive impact on oncology, immunotherapy, pharmacology and diagnostics.”