QIAGEN and DiaSorin launch automated testing for latent TB infection with QuantiFERON-TB Gold Plus technology on widely used LIAISON platforms
CE-marked workflow enables efficient, high-throughput screening for tuberculosis control efforts in Europe and other markets; introduction in United States expected in 2019 and China in 2020
Hilden, Germany, and Saluggia, Italy, September 17, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and DiaSorin (FTSE Italy Mid Cap: DIA) today announced the introduction of an automated, CE-marked workflow for QIAGEN’s QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT) and a novel DiaSorin LIAISON Test on widely used immunodiagnostic instruments from DiaSorin. Laboratories in Europe and other markets will now be able to process QFT-Plus BCT, the fourth-generation modern gold standard for latent tuberculosis (TB) detection, with DiaSorin’s flexible, efficient LIAISON systems. Availability is planned for the United States in 2019 and China in 2020.
The LIAISON QuantiFERON-TB Plus Test was developed in a partnership between QIAGEN and DiaSorin to help address accelerating conversion of the global latent TB testing market to the modern blood-based QuantiFERON technology. The launch offers LIAISON customers efficient, high-throughput detection with QFT-Plus as part of the system’s broad content menu, and QFT-Plus customers will gain an option for full automation of laboratory handling to support TB control efforts. More than 7,000 LIAISON systems have been placed worldwide, primarily in hospital laboratories.
“We are pleased to offer customers this compelling, automated solution for the LIAISON QuantiFERON-TB Plus Test, enabling an improved workflow of the world’s leading test for latent TB infection. Increasingly, public health initiatives around the world are using QFT-Plus in screening at-risk patients to safeguard against progression from latent infection to active, life-threatening tuberculosis,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “LIAISON users will benefit from adding our unique latent TB test to their laboratory menus and will thereby be able to provide highly accurate screening and novel diagnostic insights. QuantiFERON-TB customers will benefit from LIAISON’s best-in-class, random access, continuous loading and automated workflow. We look forward to working closely with our partners at DiaSorin.”
“I’m really excited about the tremendous opportunity we have in front of us through this alliance with QIAGEN” said Carlo Rosa, Chief Executive Officer of DiaSorin Group. “The collaboration between the two companies can provide a very unique solution to the current LTBI tests demand in the labs all over the world. Our existing LIAISON platforms installed base, combined with the launch of our new CLIA platform, LIAISON XS, in early 2019, will provide new labs the opportunity to approach this relevant testing routine with a very robust and fully-automated solution. I’m convinced that this collaboration with QIAGEN can bring our companies to find additional diagnostic applications where we can leverage on the QuantiFERON technology and the LIAISON installed base, strengthening our positioning in the diagnostic market”.
QuantiFERON assays are based on two components: (1) QuantiFERON Blood Collection Tubes, which contain key components of the test reaction that is uniquely performed in-tube after blood collection; and (2) QuantiFERON test detection, which is used to measure the release of interferon gamma after in-tube incubation. Customers using the new latent TB detection workflow for LIAISON systems will purchase the detection components from DiaSorin and the blood collection tube kits from QIAGEN.
QIAGEN and DiaSorin initiated a collaboration in 2017 to develop new tests for the LIAISON family of analyzers based on QIAGEN assay technologies. The QuantiFERON detection workflow is the first to emerge. Additional tests based on QuantiFERON technology, which provides a unique, efficient way to detect asymptomatic infections and other risks that cannot be discovered with standard diagnostic technologies, are planned for adaptation to the LIAISON platforms.
In addition to the partnership with DiaSorin, QIAGEN recently has signed a collaboration agreement with Hamilton Robotics to further improve the automation of QuantiFERON-TB Gold Plus through the integration of Hamilton’s Microlab® STAR™ automated liquid handling workstation into the QFT-Plus assay workflow. This preanalytical automation solution can be potentially combined with DiaSorin instrumentation.
QuantiFERON-TB Gold Plus is registered in more than 75 countries in North America, Europe, Asia, Africa and Latin America. QIAGEN’s QuantiFERON-TB Gold (QFT) and QFT-Plus tests are the market-leading blood tests for latent TB, with faster, less labor-intensive and more accurate insights than the century-old tuberculin skin test. QFT-Plus also has the future potential to deliver increased clinical utility by adding measurement of CD8+ T-cell immune response to detection of CD4+ response. CD8+ T-cells have been shown to play an important role in the development of active TB, and QFT-Plus has been cited by international agencies for its potential benefit among migrants and other populations.
QIAGEN has targeted to exceed 300m in sales with the QuantiFERON portfolio by 2020 and believes that the relationship with DiaSorin has both a strategic and financial benefit for the Company.
Tuberculosis is a contagious bacterial infection spread primarily through coughing by patients with the active pulmonary form of the disease. In 2016, there were 10.4 million new cases of active TB worldwide and 1.7 million deaths from TB, according to WHO estimates. In latent tuberculosis infection, the bacterium infects a person but produces no symptoms unless it progresses to active disease, at which stage the patient is highly contagious. As part of comprehensive programs to eradicate TB, WHO and other international organizations have expanded their guidelines for screening high-risk individuals and treating those with latent infection to help prevent further contagion and reduce the disease burden.