• QuantiFERON-TB Gold Plus (QFT-Plus), the fourth generation of the modern gold standard for TB detection, receives Chinese NMPA approval as test for active tuberculosis detection

• World Health Organization (WHO) endorses QFT-Plus as alternative IGRA test for diagnosis of TB infection, recommends new QIAreach QFT for research use in epidemiological settings

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QuantiFERON tuberculosis (TB) testing solution has gained additional momentum with the approval of the fourth generation of this modern gold standard test in China and a new endorsement from the World Health Organization (WHO).

Among the recent developments:

• China’s National Medical Products Administration (NMPA) has approved QuantiFERON-TB Gold Plus (QFT-Plus) for TB diagnosis, including active TB infections. This builds on the regulatory approvals for QFT-Plus for latent TB diagnosis in the U.S. and other countries around the world, including CE-IVD marking. QFT-Plus is an important improvement over the previous version of QuantiFERON that was approved and used in China, offering even more accurate detection of infection, including in immunocompromised people. In China, all available IGRA tests including QFT-Plus are licensed to rule out active TB – other countries also approve these tests to detect the latent form of the TB disease (LTBI), in which people are infected, and have the potential to develop active disease. Since 2013, more than 1.5 million people in China have been tested for active TB infection using the proprietary QuantiFERON technology.

• The WHO has renewed its recommendation that blood-based Interferon-Gamma Release Assays (IGRA) are an alternative for the diagnosis of TB infection, in addition to the Tuberculin Skin Test (TST). In its latest policy statement, the WHO also took the first step towards endorsing the use of QIAGEN’s QIAreach QuantiFERON-TB (QIAreach QFT) - a portable, battery-operated test for TB detection especially designed for low-resource, high-burden regions - by recommending its use for additional research in more geographical and epidemiological settings. QIAreach QFT was launched in late 2021 and was recently approved by the Global Fund’s Expert Review Panel Diagnostics (ERPD). This approval means QIAreach QFT may now be procured by public health programs and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources, as well as made available through the Stop TB Partnership’s Global Drug Facility (GDF).

“The approval of the latest version of QuantiFERON TB-Gold Plus in China strengthens the global coverage that QIAGEN can offer in the fight against TB,” said Jean-Pascal Viola, Senior Vice President of the Business Area Molecular Diagnostics at QIAGEN. “The new WHO recommendation for IGRA tests also confirms the clinical performance and utility of IGRAs, and in particular the value of QFT-Plus as the modern gold standard for blood-based TB detection. Additionally, we are pleased that the WHO recognizes the potential of QIAreach QFT to become a crucial element in TB detection strategies and our commitment to leave no country behind in this fight.”

"QuantiFERON TB-Gold Plus is much easier for our laboratory technicians to use than other tests – it doesn’t require complicated lab technology and is easily scalable for the kind of high-throughput testing we need,” said Dr. Gao Lei, Professor, Institute of Pathogen Biology at the Chinese Academy of Medical Sciences. "The world needs new technologies and methods to contest TB – and QIAGEN’s IGRA technology is playing a crucial role here.”

QuantiFERON-TB Gold Plus and QIAreach QFT use blood samples to test for interferon-gamma proteins released from T-cells that have had contact with TB bacteria. They are the fastest and most convenient IGRA tests, as they do not require the isolation of white blood cells. Single-visit IGRA tests are a quantum leap from the use of Tuberculin Skin Test, which requires two visits to health professionals and a visual inspection to detect an infection.

Over two billion people worldwide are estimated to have LTBI. Clinical studies have shown that approximately 10% of these people – who are neither ill nor show symptoms – will develop active TB in their lifetimes. The active form of the disease is infectious, and particularly dangerous for people with weakened immune systems as a result of the use of immunosuppressive medications or comorbidities such as diabetes, HIV and other conditions. The active form of tuberculosis most often affects the lungs and can spread easily. While a healthy immune system can successfully fight TB, the disease is often fatal if left untreated – especially for people with weakened immune systems. In 2020, about 1.5 million people died worldwide from TB, according to the WHO.

For more information, please visit www.qiagen.com

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, 2021, QIAGEN employed more than 6,000 people in over 35 locations worldwide. Further information can be found at 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).

Category: Corporate

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