QIAGEN's QuantiFERON-TB Gold Plus Gains Approval in Canada

Business Wire 14-Jan-2019 4:00 PM

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

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.

Please find the full press release here

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