QIAGEN’s tuberculosis blood test QuantiFERON-TB Gold Plus gains CE-marking under new EU IVDR framework

Original from: business wire

QIAGEN N.V. today announced the certification of QuantiFERON-TB Gold Plus (QFT-Plus) – the world’s leading tuberculosis (TB) blood test – under the European Union’s 2017/746 In Vitro Diagnostic Medical Devices Regulation (IVDR) which is replacing the 98/79/EC In Vitro Diagnostic Directive (IVDD). QFT-Plus is QIAGEN’s trusted test, endorsed by the WHO, that aids in indirect detection of the bacteria that causes tuberculosis (TB). The IVDR certification of QFT-Plus follows the QIAGEN ipsogen JAK2 RGQ PCR Kit as well as the NeuMoDx Systems and reagents, which gained IVDR CE-marking in late 2022.

The updated set of rules, which became effective May 26, 2022, is now imposing higher and broader requirements on IVD manufacturers to receive CE-marking for their products. It also includes stronger oversight by independent EU-designated organizations, referred to as Notified Bodies. QuantiFERON-TB Gold Plus is classified as a Class C device under IVDR. With its more stringent mandates, the European regulatory framework comes closer to the FDA IVD regulations in the US and aims to ensure higher quality of health services for patients.

“Our teams have been able to demonstrate that QuantiFERON-TB Gold Plus is compliant to the IVDR requirements through stringent regulatory review. Our customers can approach the transition with confidence and continue to use QFT-Plus as the modern gold standard for blood-based tuberculosis detection,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN.

QIAGEN is committed to the highest standards of quality and has therefore pledged to transition over 180 products that fall within the scope of IVDR to ensure full compliance with the new rules, which apply to all manufacturers commercializing IVD medical devices on the EU market.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2022, QIAGEN employed approximately 6,200 people in over 35 locations worldwide.

Source: QIAGEN’s tuberculosis blood test QuantiFERON-TB Gold Plus gains CE-marking under new EU IVDR framework