Qiagen, DiaSorin partner to offer fully automated TB detection with QFT-Plus available on LIAISON analyzer systems

This addition will enable customers of both companies to process QuantiFERON-TB Gold Plus (QFT-Plus), the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on LIAISON family platforms. Laboratories using QFT-Plus to safeguard at-risk patients by screening for latent TB infection will have access to a fully automated, flexible workflow on LIAISON family analyzers in addition to the currently available workflow solutions. More than 7,000 LIAISON systems have already placed worldwide, primarily in hospital laboratories.

QFT-Plus marks the first assay from Qiagen’s QuantiFERON portfolio that is planned to be adapted for use on the LIAISON family systems. Additional assays based on QuantiFERON technology, which offers a unique, efficient way to detect asymptomatic infections and other risks that cannot be discovered with standard diagnostic technologies, are under consideration.

QuantiFERON assays such as QFT-Plus 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) the QuantiFERON test read-out components, which are used to measure the release of interferon gamma after in-tube incubation. QFT-Plus currently runs in laboratories on standard detection equipment.

Under the agreement, DiaSorin and Qiagen are developing a fully automated version of the QuantiFERON test read-out components that can be used with the QuantiFERON-TB Plus test, as well as future QuantiFERON-based tests that will be adapted for use on LIAISON.

DiaSorin and Qiagen plan to launch a CE-marked version of the new QuantiFERON read out components for use on LIAISON XL in the third quarter of 2018, while the U.S. availability is planned for 2019. The companies expect to launch the new test in China in 2020.

Once the new read-out product is launched, customers will be able to purchase the QuantiFERON Blood Collection Tube kit for use on LIAISON family systems from Qiagen. DiaSorin will be responsible for development and commercialization of the QuantiFERON read-out test components, which is being done under a license from Qiagen and includes components purchased from Qiagen. Customers of the currently available QuantiFERON-TB Gold Plus test will continue to purchase it through Qiagen.

This partnership comes amid accelerating conversion of the global latent TB testing market to the modern blood-based QuantiFERON test. Qiagen reached an important milestone at the end of 2017 with an estimated 40 million QuantiFERON-TB tests conducted for patients around the world since its initial launch.

Carlo Rosa, chief executive officer of DiaSorin Group, commented: “I’m really excited about this market opportunity that sees DiaSorin joining forces with Qiagen as a leading global provider of molecular testing solutions. This collaboration creates the opportunity to add unique and differentiating content to the broad assay menu of our flexible, efficient LIAISON analyzers. We believe that we will be able to further improve this opportunity with the launch of our new future platform, LIAISON XS, creating an intriguing solution for mid-sized laboratories, both in Europe and the U.S. as well as China. This partnership highlights our commitment to driving our success story as a leader in immunodiagnostics, providing reliable solutions to laboratories around the world based on our extensive CLIA menu and the robustness of our LIAISON family analyzers.”

Peer M. Schatz, chief executive officer of Qiagen N.V, commented: “We are pleased to partner with DiaSorin and create a compelling fully automated solution for our QuantiFERON-TB test, and plans for this to be followed by more QuantiFERON-based tests in the future. A large percentage of potential and existing QuantiFERON-TB customers are already LIAISON customers, and adding our tests to this broad menu will offer significant benefits for laboratory automation and efficiency. QuantiFERON customers will benefit from a best-in-class, random access, continuous loading and fully automated workflow with QuantiFERON assays embedded in a full menu of assays. Diagnostic labs place a high value on unique content, a full menu and excellent automation. Together, we can drive faster conversion of latent TB testing – estimated at more than 65 million tests annually – and improve the lives of people around the world at risk for this potentially fatal disease.”

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. 

Headquartered in Italy and listed in the FTSE Italia Mid Cap Index, DiaSorin is a global leader in the In Vitro Diagnostics (IVD) field. For over 40 years the company has been developing, producing and marketing reagent kits for IVD worldwide.

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