New study published in Lancet Respiratory Medicine highlights QIAGEN’s QuantiFERON-TB potential to predict active tuberculosis risk in infants
Feb 16 2017

New study published in Lancet Respiratory Medicine highlights QIAGEN’s QuantiFERON-TB potential to predict active tuberculosis risk in infants

Results suggest benefits of quantitative screening of young children in countries with high TB burden

Hilden, Germany, and Germantown, Maryland, February 16, 2017 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that data published in The Lancet Respiratory Medicine journal shows screening with QuantiFERON-TB Gold (QFT) can detect latent tuberculosis (TB) infection in otherwise healthy young children and can predict which are likely to progress to the active stage of this life-threatening respiratory disease.

Results from the study of more than 2,500 young children in South Africa suggest that screening with the modern QuantiFERON-TB blood test could save lives in countries with a high TB burden by identifying those children most at risk of developing active disease. The study noted young children are particularly vulnerable to TB, with up to 20% of those infected by the bacteria developing the active TB disease.

“This study marks a true milestone. For the first time, there is a test that has demonstrated the potential to quantify the risk for young children to develop active tuberculosis. Researchers found that those with a QuantiFERON-TB test result above a certain threshold were far more likely than others to get sick with the active disease. TB is a terrible killer of children in high-burden countries, so early diagnosis and treatment could save many lives,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at QIAGEN.

The study was authored by researchers at the Stanford University School of Medicine, the South African Tuberculosis Vaccine Initiative, London School of Hygiene & Tropical Medicine, the Desmond Tutu HIV Centre, the Jenner Institute at Oxford and Aeras, a non-profit devoted to development of TB vaccines.

Medical data was analyzed from more than 2,500 South African babies who were all healthy, HIV-negative and had no known TB exposure who were enrolled from 2009 to 2012 in a trial of a potential TB vaccine that in the end did not prove effective in preventing TB. The researchers in the trial used QuantiFERON to measure infection in the children, who were all tested at the start of the trial and again at one year and two years. When the 2,512 children in the study were tested at a year, 172 of them, or 6.8%, were found to be positive carriers of the TB bacteria, a very high rate of infection, the researchers reported. Of these, 30 had already been diagnosed and treated for the active disease. The researchers more closely examined the other 142 children who tested positive but hadn't yet developed TB. They found children with higher values on the QuantiFERON test results had been more likely to develop the active disease, making it the first study to show the importance of assessing different levels of the test values in children.

In South Africa and many other countries, most children are never tested for latent TB infection when it is still preventable from converting to active disease. Instead, active TB is found passively, after seeking care because of symptoms from advanced TB disease. TB is the leading cause of death in South Africa among both adults and children. The researchers said they are now exploring the feasibility of scaling up TB screening programs for children in South Africa for prevention.

The test used in the South African study was QuantiFERON-TB Gold, the third generation of QIAGEN’s proprietary technology for the detection of latent infections. QFT is the modern gold standard to detect latent TB infection, but large meta-analysis studies undertaken in the past, using standard thresholds show minimal predictive value for TB progression. The results of this study show the use of quantitative values to predict risk among young children points to a new potential application.

QIAGEN’s fourth-generation QuantiFERON-TB Gold Plus (QFT-Plus) is now available in more than 60 countries around the world, and was recently submitted for U.S. regulatory approval. The fourth-generation test is the first assay with novel CD8 T-cell stimulating antigens. The availability of QFT-Plus to measure CD8 T-cell response has been cited by the World Health Organization (WHO) as a potential factor in identifying adults at greater risk of progressing to active TB.

Tuberculosis is a contagious bacterial infection spread primarily through the air. Patients with the active pulmonary form of this disease can spread it through coughing. In 2015, the WHO estimates about 10.4 million new cases of active TB worldwide and 1.8 million deaths from TB.

In latent TB infection, the bacterium infects a person but does not cause symptoms unless it progresses to the active disease. On a global basis, about one-third of people are estimated to have latent TB infection, and about 5-10% of those individuals, if untreated, will progress to active disease at some point. Screening of high-risk individuals and treatment for latent infection play a growing role in global tuberculosis control efforts.

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 diagnosing latent TB infection – faster, less labor-intensive and more accurate than the century-old tuberculin skin test. In 2015 QIAGEN launched QuantiFERON-TB Gold Plus in Europe and other markets with CE-IVD marking. More than 30 million tests using QuantiFERON-TB technology have been distributed globally. To learn more about QFT and QFT-Plus, please visit http://wwwQuantiFERON.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 December 31, 2016, QIAGEN employed approximately 4,700 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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