QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that its QIAstat-Dx syndromic testing solution is expected to be available soon for use in Japan with a SARS-CoV-2 Respiratory Panel that can detect more than 20 pathogens from a single patient sample.

The availability in Japan is expected in mid-2023 after decisions on reimbursement levels and comes as the next step after the recent granting of IVD approval for the test. The entry into Japan will add to more than 100 countries worldwide – including the United States, as well as countries across Europe and other areas of the world – where QIAstat-Dx solutions and various syndromic tests to diagnose diseases are available.

“We are pleased to announce upcoming availability of our QIAstat-Dx SARS-CoV-2 Respiratory Panel in Japan, which enhances our commitment to improving healthcare around the world,” said Jean-Pascal Viola, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. “QIAstat-Dx enables easy operation with less labor compared to standard individual PCR assays for each pathogen and provides powerful support for medical workers in respiratory medicine, pediatrics and emergency medicine.”

The system is designed to operate in laboratories and employs cost-efficient, single-use cartridges with all reagents on board and built-in sample processing.

Using multiplex real-time PCR, QIAstat-Dx detects and differentiates between multiple pathogens. QIAstat-Dx is the only syndromic testing system to provide Ct values and easy access to amplification curves. Access to this supplementary data provides additional insight, allowing for better-informed decisions for patients.

With more than 3,500 systems installed worldwide at the end of 2022, QIAstat-Dx is used in hospitals, laboratories and clinics as an easy-to-use solution for reliable diagnosis of various diseases. The first group of panels available are for the detection of respiratory or gastrointestinal pathogens or for distinguishing between meningitis and encephalitis infections.[1]

QIAstat-Dx is available in two formats: The QIAstat-Dx version that brings together up to four Analytical Modules into one integrated system, and the QIAstat-Dx Rise high-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules.1

QIAstat-Dx connects to the QIAsphere cloud-based platform that provides remote monitoring of the instruments and test status, allowing customers to receive push notifications on their personal devices. It can monitor an unlimited number of instruments across different hospitals or satellite labs, reducing system downtime and enabling fast and accurate syndromic testing. Connectivity is achieved through the Qbase hub, which can be connected to QIAstat-Dx in minimal time through hospitals’ LAN or Wi-Fi network, ensuring sensitive patient data remains within the hospital network.

QIAsphere also allows users to view and export reports on real-time local, regional and global epidemiology data through QIAsphere Insights to support epidemiological surveillance. Further, with the recent release of a medical reference app for QIAstat-Dx users, the Pathogen Guide, QIAstat-Dx is poised as a leader in digital diagnostic technology for customers around the world.