QIAGEN welcomes new evidence-based tuberculosis testing guidelines from U.S. professional societies
Dec 12 2016

QIAGEN welcomes new evidence-based tuberculosis testing guidelines from U.S. professional societies

New guidelines recommend broader use of modern blood TB tests like QuantiFERON-TB Gold over the 100-year-old tuberculin skin test

Germantown, Maryland, and Hilden, Germany, December 12, 2016 – QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today welcomed new evidence-based guidelines for TB screening that have broadened the preferential recommendation for the use of modern blood-based TB tests (tests based on interferon gamma release, or IGRAs) over the 100-year-old tuberculin skin test (TST) in a wider group of people at risk for latent or active tuberculosis infection.

QIAGEN’s QuantiFERON-TB® Gold (QFT®) is the leading IGRA in the U.S. and worldwide, with more than five million tests sold in the U.S. during the last year and seven-fold the volume of other IGRAs. This expanded preferential recommendation is expected to drive more rapid conversion from the use of the TST given that these guidelines are the first of their kind to recommend IGRAs over the TST based on disease progression risk, and not just based on patient types.

The new guidelines were the outcome of a task force supported by the American Thoracic Society (ATS), the U.S. Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America, and were published in the latest issue of Clinical Infectious Diseases. The updated guidelines on TB, a potentially lethal but preventable disease, were also endorsed by the European Respiratory Society.

In testing for latent tuberculosis infection (LTBI), a condition that produces no symptoms but can progress to the active form of TB, the task force strongly recommended performing an IGRA instead of the TST in people age 5 and older who are likely to be infected with the Mycobacterium tuberculosis bacteria that causes the disease as well as those with a low to intermediate risk of progression to active TB.

The guidelines also supported the use of an IGRA in people for whom it has been decided that latent TB testing is warranted, and also those who have either have been vaccinated with the BCG vaccine against TB or are unlikely to return for the required second visit for a TST test. Furthermore, the task force agreed with current U.S. guidelines that people at low risk for TB infection should not be tested, but any test performed in this group should be with an IGRA instead of a TST. The guidelines also recommended that children age 5 and younger continue to be tested with a TST, but can also be tested with an IGRA.

“Despite the global efforts, TB remains devastating and lethal disease that kills a person somewhere in the world every 18 seconds,” said Dr. Masae Kawamura, M.D., Senior Director, Medical and Scientific Affairs, TB Diagnostics, at QIAGEN. “The burden of LTBI is a major concern as the reservoir of future cases in the United States, and this was underscored by the involvement of the CDC and professional organizations in these recommendations. These new guidelines are essential in the fight against TB, especially since this is a preventable disease, and they will broaden the use of latent TB tests beyond the current focus on public health programs, specialty physicians and facilities under health regulations. QIAGEN is committed to supporting the fight on TB in the United States, as well as around the world, by advancing TB screening with the use of QuantiFERON as the leading blood test for TB testing.”

The publication of these guidelines follows the announcement in September 2016 of recommendations by the U.S. Preventive Services Task Force (USPSTF) that primary care physicians screen adult patients in groups at high risk for latent TB infections. The final USPSTF recommendations referred to QuantiFERON-TB Gold as reliable in screening and suggested IGRAs may be preferable in certain patient groups than the TST.

The USPSTF, an independent volunteer panel of experts in prevention and evidence-based medicine, issued its final recommendations on screening in primary care settings on September 6, replacing the prior guidance issued by the task force in 1996. The recommendations were published in the Journal of the American Medical Association. In this new set of recommendations, USPSTF now directed its recommendations to primary care clinicians, rather than to public agencies or specialists in diseases such as HIV, where latent TB screening already is a standard of care.

Tuberculosis is a bacterial infection spread primarily by coughing or sneezing of patients with the active pulmonary form of the disease. Approximately 30% of people exposed to the bacterium develop latent TB infection, and about 5% to 10% of those individuals, if untreated, will progress to active tuberculosis at some point.

QIAGEN partners with governments and health organizations around the world to fight tuberculosis – and continues to develop innovative new technologies. QuantiFERON-TB Gold is the modern standard for accuracy in latent TB infection diagnosis – faster, easier to process, less labor-intensive and more accurate than the TST and other IGRAs. The test’s clinical reliability and simpler administration enhance the accuracy of screening, especially in large-scale population screening programs, and improve the cost-effectiveness of TB control.

To learn more about QFT and QFT-Plus, please visit http://www.QuantiFERON.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 (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2016, QIAGEN employed approximately 4,600 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, 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). 

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