QIAGEN announced that its QIAstat-Dx syndromic testing systems and assays have secured CE-marking under the new European Union (EU) In-Vitro Diagnostic Medical Devices Regulation (IVDR).
The certification includes the QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting respiratory and gastrointestinal illnesses.
With the latest certification, the Netherlands-based firm has transitioned 80% of its more than 180 products to comply with the new regulations.
The new IVDR is intended to ensure the safety, quality, and effectiveness of in-vitro diagnostic devices. Products are classified in increasing risk manner, from Class A to Class D.
QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise are Class A devices. QIAstat-Dx Gastrointestinal Panel 2 is Class C, while the QIAstat-Dx Respiratory Panel Plus is Class D, the highest risk category.
The submission for IVDR certification of the QIAstat-Dx Meningitis/Encephalitis Panel is expected in the coming months.
QIAGEN molecular diagnostics business area head and senior vice president Fernando Beils said: “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 system uses multiplex real-time polymerase chain reaction (PCR) technology to detect multiple pathogens quickly, delivering results in about one hour.
It is said to show comprehensive data directly on the instrument’s touch screen, including cycle threshold (Ct) values, and amplification curves.
The product comes in the standard version, which integrates up to four Analytical Modules. Another version is the higher-capacity QIAstat-Dx Rise, capable of performing up to 160 tests per day with eight Analytical Modules.
According to QIAGEN, these rapid results help in making informed treatment decisions. These include stopping unnecessary antibiotic use for viral infections, improving patient outcomes, and supporting antimicrobial stewardship.
Available in more than 100 countries, including the US and Europe, QIAstat-Dx solutions support disease diagnosis.
The systems are being used globally by hospitals, laboratories, and clinics based on their ease of use and reliable pathogen detection.
In May, QIAGEN received EU IVDR certification for QIAGEN Clinical Insight Interpret, its medical device software for clinical decision support.
