QIAGEN welcomes new decision by U.S. Centers for Disease Control to use modern blood-based TB tests for immigration screening
Feb 20 2018

QIAGEN welcomes new decision by U.S. Centers for Disease Control to use modern blood-based TB tests for immigration screening

Gold-standard QuantiFERON-TB® Gold Plus cited as an FDA-approved option for testing

Germantown, Maryland, and Hilden, Germany, February 20th, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it welcomed a decision by the U.S. Centers for Disease Control (CDC) to require the use of modern blood-based tests (IGRA) for tuberculosis (TB) screening.

QIAGEN’s QuantiFERON-TB® Gold Plus (QFT-Plus®), the gold standard and market leader among IGRA tests, has been experiencing significant interest in immigration health surveillance around the world, and is expected to be used even more in the United States as a result of this decision.

The CDC Division of Global Migration and Quarantine provides the Department of State (DOS) and the U.S. Citizenship and Immigration Services (USCIS) with TB medical screening guidelines (referred to as Technical Instructions) for both Civil Surgeons and Panel Physicians.

The CDC recently issued a notification to all U.S. Civil Surgeons stating that it currently plans for the new  changes to medical screening guidelines to go into effect on October 1, 2018, requiring the use of FDA-approved interferon gamma release assay (IGRA) tests for tuberculosis. The use of the tuberculin skin test (TST) will no longer be allowed for use in immigration screening, including children under age 5.

The USCIS receives and adjudicates approximately six million petitions and applications annually from individuals and employers. Currently, more than one million people receive permanent lawful residence in the U.S. annually, of which approximately half are living in the U.S.. Immigration medical examinations conducted inside the U.S. must be performed by a Civil Surgeon who has been designated by USCIS. The medical examination is a required component of the application process for permanent residence. (https://www.uscis.gov/tools/reports-studies/immigration-forms-data)

“In the United States, test accuracy has never been more important as the country aggressively fights to end tuberculosis through recent policy-driven expansion of targeted testing and preventive treatment. It is currently estimated that 93% of the TB disease in the U.S. comes from the 13 million-person reservoir of latent TB infections, which primarily occurs through migration from higher burden countries,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “We look forward to working with the Civil Surgeons around the U.S. in this transition period since switching from the TB skin test to tests like QFT-Plus can eliminate false-positive results from BCG vaccination used in most countries. This makes the QFT-Plus results more accurate and believable to both the physician and the patient.”

The decision in favor of IGRA tests is based in part on the deficiencies in the TST in detecting latent TB in this target population. Many foreign-born persons have been BCG-vaccinated, particularly from countries with a high prevalence of TB. QFT-Plus has been shown to be superior to TST in BCG-vaccinated populations, yielding less false positives and the related unnecessary healthcare expenditures.

The need for effective TB control of immigrant applicants is critical given the case rate among non-U.S.–born persons (14.7 cases per 100,000 persons) was approximately 14 times higher than among U.S.-born persons (1.1 cases per 100,000 persons), according to the CDC. In 2016, a total of 68.5% of reported TB cases in the U.S. occurred among non-U.S.–born persons, the CDC data showed.

The CDC announcement follows the U.S. 2017 launch of QFT-Plus, the fourth-generation assay of QIAGEN’s world-leading series of interferon gamma release assays (IGRA). QFT-Plus adds innovative CD8 T-cell stimulating antigens to existing CD4 antigens, which provides a broader immune assessment of TB infection. CD8+ T-cells have been shown to play an important role in Mycobacterium and sets a new benchmark in TB testing.

QFT-Plus is registered in more than 75 countries across Europe, the Middle East, Africa, Asia and Latin America, where nearly two million of the new tests have already been used. QFT-Plus has more than 15 peer-reviewed publications to date, and studies are underway in 22 countries involve more than 30,000 patients. QFT-Plus is endorsed  by the World Health Organization (WHO) as one of two IGRAs for its campaign to eradicate TB.

Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease. In 2015, WHO estimates, there were 10.4 million new cases of active TB worldwide and 1.8 million deaths from TB. In latent tuberculosis infection (LTBI), 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, will progress to active tuberculosis at some point. Screening of high-risk individuals and treatment for LTBI play an important role in tuberculosis control efforts in the U.S. and many European countries, as well as in other developed and emerging markets around the world.

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 (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2017, 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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