Venlo, the Netherlands, and Germantown, Maryland, May 03, 2023 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it welcomed the U.S. Preventive Services Task Force (USPSTF) reaffirming a previously issued recommendation for latent tuberculosis infection (LTBI) screening by primary care physicians in populations at increased risk.
The USPSTF issued a final report on May 2 to continue the “B” recommendation for screening of these populations, building on the previous recommendation issued in 2016 by the independent volunteer panel of experts in prevention and evidence-based medicine.
This reaffirmation helps ensure that insured patients in the U.S. from risk groups for TB infection continue to have access to screening with no out-of-pocket costs to them, as the Affordable Care Act requires that insurers provide preventive services with an “A” or “B” recommendation at no cost.
The USPSTF recommendations referred to QuantiFERON-TB Gold Plus (QFT-Plus) from QIAGEN as reliable in screening. It also suggested that interferon gamma release assays (IGRAs) like QFT-Plus may have advantages in certain patient populations over the tuberculin skin test (TST) in a wider group of people at risk for latent TB infection. This is in line with guidelines from the U.S. Centers for Disease Control.
“It is important to recognize that TB is a preventable disease that still claims too many lives every year and remains a persistent public health issue in the U.S.,” said Jenny Howard, Vice President, Head of the Immune Response Franchise at QIAGEN. “We welcome this updated recommendation from the USPSTF as an important step in the fight against TB. Stepping up screening is increasingly critical to achieve the ambitious ‘End TB Strategy’ goals, especially in light of the setbacks in testing during the COVID-19 pandemic.”
QuantiFERON-TB Gold Plus is the world’s leading IGRA blood test, with millions of tests performed annually. It has benefited patients and providers by reducing the number of visits to a single blood draw with a faster turnaround time. QuantiFERON-TB Gold Plus has established itself as a superior alternative to the TST, which, as the USPSTF guidance highlights, is less effective in identifying TB infection in people who have received BCG vaccination, which are commonly used in patients from high TB burden countries, and in patients who may be unlikely to return for TST interpretation.
QuantiFERON-TB Gold Plus sets itself apart from other IGRA tests with streamlined workflow and using whole blood samples, not purified lymphocytes. Manual and automated solutions are available to accommodate laboratories from low to high throughput needs. QuantiFERON-TB Gold Plus has consistently shown a very high specificity, providing confidence that it is detecting those truly infected and not missing TB infection cases. This ongoing recommendation from the USPSTF supports the continued use of QuantiFERON-TB Gold Plus as part of the global fight against TB.
Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease. In 2020, the World Health Organization (WHO) estimated that there were 10 million new cases of active TB worldwide and 1.5 million deaths from TB.
In the case of latent tuberculosis infection, the bacterium infects a person but produces no symptoms unless it progresses to the active disease.
On a global basis, approximately one out of four people are estimated to have latent TB infection, and about 5-10% of those individuals, if untreated, may progress to active tuberculosis at some point. Risk of progression to active TB is much higher in people with immune system impairment.
Screening of high-risk individuals and treatment for LTBI plays an important role in TB control efforts in the U.S. and many European countries, as well as in other developed and emerging markets around the world.
To learn more about QFT and QFT-Plus, please visit http://www.qiagen.com/applications/tb-management.
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.
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.
Source: QIAGEN N.V.