Qiagen has received the CE mark for its QIAstat-Dx syndromic testing systems and associated assays under the European Union (EU)’s In Vitro Diagnostic Regulation (IVDR).
The certification covers the company’s low-risk, Class A devices such as QIAstat-Dx Analyzer, QIAstat-Dx Rise automated syndromic testing platform, and associated instruments, along with higher-risk Class C and Class D (highest risk) QIAstat-Dx Gastrointestinal Panel 2 and QIAstat-Dx Respiratory Panel Plus, respectively.
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The Netherlands-based company also plans to secure the newer IVDR certification for other products in its portfolio, with a certification for its QIAstat‑Dx Meningitis/Encephalitis Panel expected next.
The IVDR certification is part of the EU’s medical device regulations (MDR) whereby approved products have to renew their approvals based on the newer requirements. The newer regulations became effective in May 2017 but companies have a transition period to recertify their devices, up to 31 December 2027 for high-risk devices and 31 December 2028 for lower-risk devices.
The QIAstat-Dx system uses multiplex real-time polymerase chain reaction (PCR) technology to improve the detection rate of pathogens. The company states that its QIAstat-Dx Respiratory Panel Plus covers 21 viral and bacterial targets, which can cause upper respiratory infections and can give out results in one hour. This marks an improvement on the conventional methods, which require multiple days for pathogen incubation and identification.
Qiagen is also expanding its portfolio by partnering with companies to develop diagnostic assays. Earlier this month, the company partnered with Eli Lilly to develop an in vitro diagnostic (IVD) that can detect apolipoprotein E (APOE) genotypes for diagnosing Alzheimer’s disease. The test can detect all three APOE genes, whose presence is associated with a higher risk of developing Alzheimer’s, and will be added to the QIAstat-Dx testing platform.
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By GlobalDataIn May, Qiagen partnered with the FBI to develop a novel digital PCR assay capable of detecting and quantifying minimal amounts of DNA with high accuracy for forensic use. The assay is expected to run on Qiagen’s QIAcuity automated digital PCR devices.
