QIAGEN welcomes U.S. guidance for latent TB testing in primary care
Sep 08 2016

QIAGEN welcomes U.S. guidance for latent TB testing in primary care

U.S. Preventive Services Task Force issues recommendations to screen high-risk patients

Germantown, Maryland, and Hilden, Germany, September 8, 2016 QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today welcomed recommendations issued by the U.S. Preventive Services Task Force (USPSTF) that primary care clinicians screen adult patients in groups at high risk for latent tuberculosis infection (LTBI), a condition that produces no symptoms but can progress to active tuberculosis, a highly contagious and potentially fatal disease. The final USPSTF recommendations refer to QIAGEN’s QuantiFERON-TB® Gold (QFT®) as a test proven to be reliable in screening for latent TB infection and suggest that this class of test may be preferable in certain patient groups.

“The Task Force acknowledges tuberculosis as ‘an important, preventable disease’ in the United States and the new LTBI guidelines are unprecedented in that it expands the scope of testing to all providers, and calls upon primary care physicians to play a key role in ending tuberculosis in the United States.” said Dr. Masae Kawamura, Senior Director of Medical and Scientific Affairs for QIAGEN. “Up to now, TB screening in the United States and most countries has been limited to public health programs, specialty physicians, and facilities under health regulations.  The new directive of the USPSTF LTBI guidelines for primary care clinicians is truly an important step to eliminate tuberculosis in the US.”

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. “Traditionally, prevention of tuberculosis has relied on public health systems; however, more recently, screening for LTBI has become a relevant primary care issue,” the panel said.

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, the USPSTF noted. The prevalence of latent TB infection is hard to determine with precision, but the panel cited estimates in the range of 4.7% to 5% of the population. In the United States, 9,563 new cases of active TB (which equates to about 0.003% of the population) were reported in 2015, according to the U.S. Centers for Disease Control (CDC). It was the first time numbers of newly reported TB cases have risen since the AIDS crisis in the 1980s.

The task force recommended latent TB screening of patients at increased risk, including former residents or individuals born in countries with a high prevalence of tuberculosis, as well as persons who have lived in congregate settings such as homeless shelters or correctional facilities. In 2015, 66.2% of U.S. cases of active tuberculosis affected foreign-born persons. High-risk countries cited by the USPSTF include Mexico, the Philippines, Vietnam, India and China, as well as Haiti and Guatemala. Agreeing with guidelines issued by the CDC, the USPSTF recommended screening with either the tuberculin skin test (TST) or interferon-gamma release assays (IGRAs). IGRAs, also known as TB blood tests, may be preferable for patients who have received the BCG vaccine or may be unavailable for a follow-up visit, the panel noted. The TST requires a clinician to “read” the skin reaction 24 to 72 hours after administering the test, while QuantiFERON-TB Gold requires only one visit for screening a patient. QIAGEN has demonstrated that IGRA tests are not only more efficient and effective, but also more cost effective than the use of traditional TST test.

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, less labor-intensive and more accurate than the tuberculin skin test. The test’s clinical reliability and simpler administration enhance the accuracy of screening and improve the cost-effectiveness of TB control. To date, more than 20 million tests using QuantiFERON-TB technology have been distributed globally.

To learn more about QFT and QFT-Plus, please visit http://www.QuantiFERON.com.



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 June 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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