QIAGEN welcomes new guidelines from American Academy of Pediatrics for detecting tuberculosis infection in children
Modern blood tests such as QuantiFERON-TB now recommended for patients ages 2 to 18
Germantown, Maryland, and Hilden, Germany, June 4, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it welcomes new guidelines from the American Academy of Pediatrics (AAP) that recommend screening at-risk children as young as two years old for latent tuberculosis (TB) infection. The AAP guidelines include recommendations regarding testing with interferon gamma release assays (IGRAs) such as QIAGEN’s QuantiFERON-TB Gold (QFT) or QuantiFERON-TB Gold Plus (QFT-Plus). The new standards were published June 1st in the association's Red Book: 2018 Report of the Committee on Infections Diseases.
The pediatric guidelines come as authorities around the world are expanding the role of latent TB screening in global tuberculosis control efforts. For example, the World Health Organization (WHO) recently endorsed the use of IGRAs for diagnosis of latent TB infection and cited QuantiFERON-TB Gold as one of two recommended alternatives to tuberculin skin tests (TSTs) in its Essential Diagnostics List. Starting October 1, 2018, the U.S. Centers for Disease Control (CDC) will require use of an FDA-approved IGRA for tuberculosis screening and will no longer allow use of the tuberculin skin test for immigration screening, including for children under age 5. Other organizations also have expanded their recommendations.
“We are pleased to see the American Academy of Pediatrics lowering its threshold age for use of IGRAs, which resonates with the growing global recognition by TB control experts of the value of using the most accurate diagnostic tests available. As part of comprehensive efforts to eradicate this life-threatening disease, latent TB infection can be detected in at-risk individuals and treated to prevent progression into active TB,” said Dr. Masae Kawamura, M.D., Senior Director, TB Medical and Scientific Affairs, at QIAGEN.
The new AAP guidelines are based in part on a study to be published in the peer-reviewed journal Pediatrics in June comparing IGRAs, primarily QuantiFERON-TB Gold, with the 120-year-old tuberculin skin test. In the largest pediatric study of IGRA performance in North America, the authors found IGRAs delivered better sensitivity to skin tests in children age 5 to 18 with confirmed TB disease. The study recommends increased access to IGRAs as the “test of choice” for that group in high-resource, low-burden areas. Among children under age 5, IGRAs showed equal sensitivity to TSTs. The authors also noted that skin tests have potential for higher false-positives than IGRAs due to interference with BCG vaccination. In children under age 2, TB testing with either method had reduced sensitivity.
Tuberculosis is a contagious bacterial infection spread primarily through coughing by patients with the active pulmonary form of the disease. In 2016, there were 10.4 million new cases of active TB worldwide and 1.7 million deaths from TB, according to WHO estimates. In latent tuberculosis infection (LTBI), the bacterium infects a person but produces no symptoms unless it progresses to active disease, at which stage the patient is highly contagious. As part of comprehensive programs to eradicate the disease, the WHO has recently issued and expanded its guidelines for screening high-risk individuals and treating them for LTBI as an effective tool to prevent further contagion and reduce the disease burden.
Recent guideline expansions follow the 2017 U.S. launch of QuantiFERON-TB Gold Plus, the fourth-generation test in QIAGEN’s world-leading series of IGRAs. QFT-Plus is registered in more than 75 countries across Europe, the Middle East, Africa, Asia and Latin America, and nearly two million of the new tests have already been used. QFT-Plus adds innovative CD8 T-cell stimulating antigens to existing CD4 antigens, providing a broader immune assessment of TB infection and setting a new benchmark in TB testing. CD8+ T-cells have been shown to play an important role in Mycobacterium. QFT-Plus also is endorsed by WHO as one of two IGRAs for the group’s global campaign to eradicate TB.
To learn more about QuantiFERON-TB tests and tuberculosis control, please visit www.quantiferon.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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected sales, adjusted net sales and adjusted diluted earnings per share 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; 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 (SEC).