CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 2022—Qiagen announced test enhancements to its QIAstat-Dx, a fully integrated molecular diagnostic testing solution with one-step sample processing that provides results in about one hour. The company is awaiting U.S. regulatory approval of a gastrointestinal panel designed to detect 22 common viral, bacterial, and parasitic pathogens that can cause potentially life-threatening infections. Qiagen has also registered for CE marking a meningitis/encephalitis panel designed to analyze 15 pathogens simultaneously and help distinguish between meningitis and encephalitis.
The company is planning to launch midyear in Europe its QIAstat-Dx Rise platform with the CE-IVD mark. QIAstat-Dx Rise has random-access capacity to hold up to 18 different tests for processing and features a “smart drawer” that allows for continuous loading. The submission for U.S. regulatory approval is planned for the end of this year.