LIAISON QuantiFERON-TB Gold Plus Test Receives FDA Approval for U.S. Launch, Advancing Modern Latent Tuberculosis Detection

VCBeat (WeChat ID: vcbeat) has learned that on November 27, 2019, QIAGEN and DiaSorin announced the launch of an automated workflow for QuantiFERON-TB Plus (QFT-Plus) on DiaSorin’s LIAISON platform in the United States. QFT-Plus is the fourth-generation modern gold standard for detecting latent tuberculosis (TB).

The U.S. Food and Drug Administration (FDA) has approved the LIAISON QuantiFERON-TB Plus Test, co-developed by QIAGEN and DiaSorin, designed to provide simplified laboratory automation for potential TB screening, thereby facilitating the transition from tuberculin skin testing to modern blood-based QFT-Plus technology. The highly automated workflow on the LIAISON platform offers exceptional flexibility, providing QFT-Plus customers with automation options suitable for all throughput levels.

QIAGEN, a biotechnology company founded in 1984 in the Netherlands, provides technologies and products for pre-analytical sample preparation and molecular analysis solutions to customers through its subsidiaries.

DiaSorin, established in 1968, is an Italian multinational group. As a global leader in the in vitro diagnostics market and biotechnology sector, the company meets laboratory needs by developing, manufacturing, and commercializing kits for clinical diagnostics. The group operates 24 subsidiaries and five international branches, with offices across five continents and production and testing facilities at six locations worldwide.

By integrating the QFT-Plus assay into the extensive test menu of the LIAISON analyzer, customers of the LIAISON system gain access to an attractive new analytical method with significant growth potential. This workflow combines QIAGEN’s QuantiFERON-TB Gold Plus blood collection tubes (which incorporate the core QuantiFERON technology) with DiaSorin’s newly launched LIAISON QFT-Plus assay. More than 8,000 LIAISON systems are currently in use worldwide, primarily in hospital laboratories.

Thierry Bernard, Interim CEO and Senior Vice President of the Molecular Diagnostics business area at QIAGEN, stated: “We are pleased to announce the FDA approval of the QuantiFERON-TB Gold Plus Test for use on the LIAISON platform, along with the broad launch of this new automated option in the United States. QFT-Plus users can leverage LIAISON’s robust and flexible automation solutions, as well as access LIAISON’s menu, which includes over 100 tests. The LIAISON workflow for QFT-Plus was launched in Europe in 2018 and is scheduled for release in China in 2020.”

Carlo Rosa, CEO of the DiaSorin Group, stated, “Today we have taken an important strategic step to advance the development of the most advanced testing solutions for latent tuberculosis infection on the market. The LIAISON QuantiFERON-TB Gold Plus Test has been available in Europe since September 2018 and is now launched in the United States on the LIAISON platform. We believe this laboratory-based solution will further strengthen our leading position in the industry.”

(Compiled by Jiang Ying)