QIAGEN’s QuantiFERON®-TB Gold Plus gains approval in Canada
Fourth generation latent TB blood test provides flexible workflow and novel CD8 technology for a more complete picture of patients' immune response to tuberculosis infection
Germantown, Maryland and Hilden, Germany, January 14th, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the Health Canada regulatory approval of QuantiFERON®-TB Gold Plus (QFT®-Plus) as an in vitro diagnostic test to detect latent tuberculosis (TB) infection. QFT-Plus is the fourth generation of QIAGEN’s market-leading QuantiFERON-TB technology, combining a new flexible blood collection workflow with innovative CD8 T cell technology to enable comprehensive TB immune response detection.
“QuantiFERON-TB Gold Plus sets a new benchmark in TB testing with the addition of specific CD8 T cell stimulating antigens. Many clinicians have already realized the patient-centered aspects of a single visit to get a result and accuracy of laboratory testing over the tuberculin skin test. The proprietary CD4/CD8 T cell technology of QFT-Plus has the potential to provide important insights for high-risk patients such as contacts exposed to active TB or HIV-positive persons while maintaining high specificity,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “Fully implementing TB elimination strategies in Canada will require testing that is both patient and doctor centered. QFT-Plus fulfills this need, as well as providing better surveillance capacity to tuberculosis programs with its electronic results.”
QFT-Plus advances the science of TB testing with innovative antigens that measure the cell-mediated immune response to tuberculosis infection from both CD4 and CD8-T cells – providing a broader assessment of TB infection. CD8-T cells have been shown to play an important role in Mycobacterium tuberculosis immunity.
QFT-Plus includes the following new features:
- Optimized CD8 T cell responses – facilitating research on patient risk stratification of latent TB infections developing into active disease. Published evidence underlines the future potential of CD8 T cells for distinguishing active from latent TB, discerning recent vs. old infections, detecting TB in certain populations such as HIV co-infection and young children, as well as assessing patient responses to TB treatment. No other test is optimized for both CD4 and CD8 T cell responses and the QFT-Plus tube format using TB1 and TB 2 tubes allows for clear enumeration of both CD4 and CD8 T cell immune response in suspension.
- Expanded blood collection options – enabling customers to take control of the TB testing workflow with blood collection options for flexibility in collection and transport. QFT-Plus offers a new standard single-tube collection option that allows larger volumes or remotely collected blood samples to be processed up to 53 hours after venipuncture for flexible transport to the lab. The existing “assay in collection tube” design for immediate stimulation of the blood sample continues to provide a direct draw option with the identical transport times as QuantiFERON-TB Gold (QFT), the third-generation assay.
- High sensitivity and specificity – QFT-Plus has a specificity of >97% and a sensitivity of >94%, producing more accurate results than the century-old tuberculin skin test (TST).
The approval of QFT-Plus in Canada follows its 2017 approval in the US and successful uptake of the test 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. More than twenty peer-reviewed publications to date have supported the performance of QFT-Plus, and studies underway in 22 countries involve more than 30,000 patients. QFT-Plus is the only IGRA test on the pathway to evaluation by the World Health Organization (WHO) for its global 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 2017, the World Health Organization (WHO) estimates that there were 10.0 million new cases of active TB worldwide and 1.6 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 three 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 Canada, the U.S. and many European countries, as well as in other developed and emerging markets around the world.
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 September 30, 2018, QIAGEN employed approximately 4,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
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