Netherlands-based diagnostic solutions provider Qiagen has launched a next-generation, fully integrated molecular analysis panel in Europe for the detection of gastrointestinal (GI) syndromes.
The multiplex GI panel for QIAstat-Dx can identify the 24 most common viral, bacterial and parasitic pathogens responsible for GI infections.
QIAstat-Dx features cost-efficient, single-use cartridges with built-in sample processing and provision for reagents. The system is said to be capable of offering insights into the accurate cause of syndromes within one hour.
Qiagen’s portfolio also includes a respiratory panel for QIAstat-Dx. This panel analyses 21 viral and bacterial pathogens such as sub-types of influenza, coronaviruses and pneumonia to help in differentiating the causes of acute respiratory tract infections.
Already approved in Europe, the QIAstat-Dx system and the GI and respiratory panels also obtained registration in Australia.
Qiagen is currently working on US regulatory submission for QIAstat-Dx and the panels, with approvals expected next year. It intends to additionally launch a QIAstat-Dx multiplex test for meningitis during the same year.
The company is also developing a deep menu of assays for syndromic testing in other therapeutic areas, including cancer.
Qiagen Molecular Diagnostics business area senior vice-president Thierry Bernard said: “Hospitals, laboratories and clinics are embracing QIAstat-Dx as an easy-to-use, next-generation solution for reliable diagnosis of complex syndromes.
“With less than one minute of hands-on time and results in about an hour, a clinic assistant or technician can run multiple samples and gain reliable, highly sensitive molecular insights that differentiate the causes of respiratory or gastrointestinal syndromes.”
The number of test panels currently being run for GI syndromes is estimated to be 2.6 million per year in the US and approximately two million in Europe.
Qiagen anticipates the total addressable market for respiratory syndromes and flu testing to reach around 1.5 million tests per year in the US and 1.1 million in Europe.