On October 13, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the certification of its leading in-vitro diagnostic (IVD) kit and its fully automated NeuMoDx platforms under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR) replacing the previous IVDD rules since May (Press release, Qiagen, OCT 13, 2022, View Source [SID1234621983]). The ipsogen JAK2 RGQ PCR Kit used for myeloproliferative neoplasms (MPN), a certain type of blood cancer, is now QIAGEN’s first IVD kit with IVDR CE-marking under Class C.
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The updated set of rules that became effective May 26, 2022, is now imposing higher and broader requirements on IVD manufacturers to receive CE-marking for their products. For example, the change includes a new risk-based classification system that ranks all IVDs from A for lowest to D for highest risk, as well as a stronger oversight by independent EU-designated organizations, so-called Notified Bodies. With its more stringent mandates, the European regulatory framework comes closer to the FDA IVD regulations in the US. The new EU regulation will ensure a higher level of protection further reinforcing patient safety. It will allow laboratories to work with high-end reagents, further increasing the quality of their results.
QIAGEN is committed to the highest standards of quality and has therefore pledged full compliance with the new rules, which apply to all manufacturers commercializing IVD medical devices on the EU market. Last year QIAGEN completed the required audit of its quality management system (QMS) through a notified body without major observation – also related to IVDR – marking a first key milestone towards the company’s IVDR compliance. Based on this result, QIAGEN will continue to submit technical documentation in order to receive certifications across the entire IVD portfolio.
With the certification of its leading IVD kit and NeuMoDx platform, the company has now reached another significant milestone in its preemptive and meticulous campaign to timely transition over 180 products that fall within the scope of IVDR. The IVD kit is now classified under Class C, according to the new regulation. The ipsogen JAK2 RGQ PCR Kit provides highly sensitive and accurate leukemia biomarker detection, supporting the evaluation of suspected MPN patients, as well as monitoring those already diagnosed. The NeuMoDx rapid, integrated PCR testing platforms for mid- and high throughput are now classified under Class A and currently offer 16 regulated assays for different infectious diseases in Europe.
"Building on our extensive regulatory experience, QIAGEN experts across our business areas are working tirelessly to ensure QIAGEN’s global quality management and products are IVDR-ready and compliant," said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. "Our customers can expect to receive certified and approved products from QIAGEN, and will profit from improved clinical performance thanks to this enhanced, sustainable and transparent regulatory framework. In addition, they will benefit from our lab-developed test capabilities of our NeuMoDx offering that will not be impacted by the new regulatory framework."
The transition period for IVDs has ended on May 26, 2022, but has been extended under certain conditions. However, European labs and clinicians supplied by QIAGEN can approach the transition with confidence, as the company has been at the forefront of developing and implementing the new regulations.
Following this significant step in the transition to new EU standards, passing the QMS audit and obtaining the product’s declaration of conformity, QIAGEN will now commence implementation of the updated labelling for these products over the coming month and will announce the release of individual products accordingly.