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QIAGEN’s tuberculosis blood test QuantiFERON-TB Gold Plus gains CE-marking under new EU IVDR framework
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QIAGEN has announced the certification of its QuantiFERON-TB Gold Plus test under the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), classified as Class C. This certification marks a key milestone in QIAGEN's compliance with EU regulations aimed at enhancing diagnostic performance and safety. The QuantiFERON-TB Gold Plus test is recognized globally, including by WHO, for its effectiveness in detecting tuberculosis. As part of its commitment, QIAGEN is transitioning over 180 products to meet the IVDR standards, ensuring continued supply and compliance moving forward.
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Certification of QuantiFERON-TB Gold Plus under stricter EU regulations enhances its market credibility.
Transitioning over 180 products to ensure compliance with IVDR demonstrates QIAGEN's commitment to quality.
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Certification of QuantiFERON-TB Gold Plus under more stringent EU regulation, classified under Class C
Certification marks milestone in QIAGEN’s transition to full compliance with new EU regulations for IVD performance and safety
QIAGEN will ensure continuous supply of QuantiFERON-TB Gold Plus
VENLO, The Netherlands--(BUSINESS WIRE)--
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) 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.
For more information about the transition from IVDD to IVDR and the corresponding time frame, please visit the IVDR support site.
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. Further information can be found at http://www.qiagen.com.
Forward-Looking Statement
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
