Venlo, the Netherlands, Oct. 04, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of its QuantiFERON-EBV RUO (Research Use Only) assay. Epstein-Barr virus (EBV), or human herpes virus 4, is estimated in various epidemiological studies to be positive in more than 90% of the world’s population and is a significant pathogen in organ transplant recipients.

This new addition to the QuantiFERON portfolio of assays is designed to support research into EBV infection and EBV-related malignancies by utilizing highly specific EBV antigens to stimulate a cell-mediated immune response, offering a dynamic view of the host’s active immune engagement with the virus.

EBV is involved in diseases ranging from infectious mononucleosis to EBV-related tumors and tumor-like lesions. In organ transplant recipients, EBV is associated with post-transplant lymphoproliferative disorder (PTLD), a potentially fatal complication after solid organ transplantation. Over 80% of PTLD cases in Europe and the U.S. are estimated to be EBV-associated.[1]

Additionally, a growing body of evidence suggests a potential connection between EBV and multiple sclerosis (MS), a chronic disease of the central nervous system estimated to affect more than 2.8 million people worldwide. EBV T-cell measurement in MS might have a potential role in understanding disease progression, treatment monitoring and developing tailored therapeutic approaches.[2]

“The QuantiFERON-EBV RUO assay represents a significant advancement in our understanding of the complex relationship between EBV and the immune system,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “This assay opens doors to innovative research, offering insights that can revolutionize patient care by guiding tailored treatment across various medical fields, including oncology and autoimmune disease.”

T-cells play a crucial role in controlling and eliminating viruses, with an effective T-cell response helping determine the course and severity of an EBV infection. Measuring the T-cell response to EBV can help researchers better understand immune responses to the virus. Specifically, in transplant patients, it has the potential to personalize immune suppressive treatment, stratify the risk of EBV-induced disease, assist clinicians in customizing the timing of testing and monitoring, and evaluate the efficiency and durability of future EBV vaccines.

QuantiFERON-EBV RUO uses a combination of CD4+ and CD8+ antigens specific to EBV nuclear antigen proteins, to stimulate lymphocytes in heparinized whole blood. This approach is different from but complementary to traditional tests, which focus on detecting viral DNA or antibodies produced in response to the virus.

Growing portfolio of QuantiFERON cell-mediated immune response tests

The new assay adds to the growing QuantiFERON portfolio of cell-mediated immune response tests. QuantiFERON-TB Gold Plus is the world’s leading IGRA blood test, with millions of tuberculosis tests performed annually. QuantiFERON SARS-CoV-2 identifies immune responses to COVID-19, while QuantiFERON-CMV is an indirect test for cytomegalovirus infections in transplant patients. QuantiFERON Monitor evaluates nonpathogen-specific cell-mediated immune responses in transplant patients. Furthermore, QIAGEN and DiaSorin collaboratively developed the LIAISON LymeDetect test, which utilizes QuantiFERON technology to detect early Lyme Borreliosis infections. [3]

QIAGEN’s QuantiFERON technology is a unique method for detecting cell-mediated immune responses from whole blood samples. It works by identifying specific T-cells in individuals with infectious agent exposure. When an infection-specific antigen is combined with the blood, rapid re-stimulation of antigen-specific T-cells occurs, leading to the secretion of interferon-gamma (IFN-γ), which can be measured as a marker of an immune response. The tests include QuantiFERON blood collection tubes with their proprietary stimulation principle and the QuantiFERON ELISA detection system to measure the resulting interferon-gamma.

For more information on QIAGEN’s QuantiFERON-EBV RUO product, click here.

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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2023, QIAGEN employed more than 6,100 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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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.

[1] Parker A, Bowles K, Bradley JA, et al. Diagnosis of post-transplant lymphoproliferative disorder in solid organ transplant recipients - BCSH and BTS Guidelines. Br J Haematol. 2010;149:675–692. https://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2010.08161.x 
[2] Bar-Or, Amit et al., “Epstein–Barr Virus in Multiple Sclerosis: Theory and Emerging Immunotherapies”, Trends in Molecular Medicine, March 2020, Published December 2019; https://doi.org/10.1016/j.molmed.2019.11.003 
[3]  Product availability may differ from country to country based on regulations and approvals.