Original from: QIAGEN

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).

This certification includes the widely-used QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The achievement underscores QIAGEN's commitment to meeting the highest standards of safety, quality, and performance, as it has already transitioned 80 percent of over 180 products to the new regulatory framework.

The new IVD regulation aims to ensure the safety, quality and effectiveness of in-vitro diagnostic (IVD) devices, overseen by independent organizations in the EU known as Notified Bodies. Devices are now classified by risk level, from A (lowest risk) to D (highest risk). The QIAstat-Dx instruments, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise, are classified as Class A devices, while the QIAstat-Dx Gastrointestinal Panel 2 is classified as a Class C device. The QIAstat-Dx Respiratory Panel Plus is classified as a Class D device – the highest risk category – highlighting QIAGEN’s capabilities to meet highest regulatory thresholds in Europe. The submission for IVDR certification of the QIAstat‑Dx Meningitis/Encephalitis Panel is expected in the coming months.

“Achieving IVDR certification for our QIAstat-Dx systems and panels is a significant milestone for QIAGEN," said Fernando Beils, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. "This certification under the new, more rigorous EU regulatory framework underscores our commitment to provide healthcare professionals with reliable and rapid syndromic testing solutions they can trust. As we continue to transition over 180 products to the IVDR framework, we remain dedicated to enhancing patient care by offering clinical customers a broad portfolio of diagnostic solutions that meet the highest standards of safety, quality, and performance.”

The QIAstat-Dx system leverages multiplex real-time PCR technology to rapidly detect and identify multiple pathogens simultaneously, delivering results in approximately one hour. It provides comprehensive data, including cycle threshold (Ct) values and amplification curves, directly on the instrument's touch screen. These fast and precise results enable healthcare providers to make informed treatment decisions, such as discontinuing unnecessary antibiotic use when viral infections are detected, thereby contributing to better patient outcomes and antimicrobial stewardship.

Available in over 100 countries, including the U.S. and throughout Europe, QIAstat-Dx solutions play a critical role in disease diagnosis worldwide. By the end of 2023, more than 4,000 QIAstat-Dx systems had been installed globally. Hospitals, laboratories, and clinics value the QIAstat-Dx range for its ease of use and reliable detection of a wide array of pathogens.

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 higher-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules.

Source: QIAGEN receives European IVDR certification for QIAstat-Dx syndromic testing instruments and assays