Qiagen said Monday that its QIAstat-Dx syndromic testing system is expected to be available soon in Japan with a SARS-CoV-2 Respiratory Panel that can detect more than 20 pathogens from a patient sample.
The Japanese launch is expected in mid-2023 after decisions are made about reimbursement levels, Qiagen said.
The entry into Japan will add to more than 100 countries -- already including the U.S. and countries in Europe and other regions -- where QIAstat-Dx and its syndromic tests to diagnose diseases are available, Qiagen said.
“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,” Jean-Pascal Viola, senior vice president and head of the molecular diagnostics business at Qiagen, said in a statement.
The system operates in laboratories and employs cost-efficient, single-use cartridges with all reagents on board and built-in sample processing, Qiagen said, adding that using multiplex real-time polymerase chain reaction (PCR), QIAstat-Dx detects and differentiates between multiple pathogens and provides cycle threshold (Ct) values and easy access to amplification curves.
QIAstat-Dx is used in hospitals, laboratories, and clinics for the diagnosis of various diseases. The first groups of panels available are for the detection of respiratory or gastrointestinal pathogens or for distinguishing between meningitis and encephalitis infections, Qiagen said. It expects to launch pan-cancer panels for its digital PCR platform QIAcuity later this year.
QIAstat-Dx is available in two formats. One version brings together up to four analytical modules into one integrated system. The other provides comprehensive testing for up to 160 tests per day using eight analytical modules.
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, the firm said.