QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Gold Plus Test and begin commercial launch

Dec. 2, 2019

QIAGEN and DiaSorin announced the U.S. launch of an automated workflow for QuantiFERON-TB Plus (QFT-Plus), the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms.

The U.S. Food and Drug Administration (FDA) approved the LIAISON QuantiFERON-TB Plus Test, developed by QIAGEN and DiaSorin to offer streamlined laboratory automation for latent TB screening, supporting the conversion from tuberculin skin tests to modern blood-based QuantiFERON technology. The highly automated workflow on LIAISON platforms provides QuantiFERON customers a powerful, highly flexible automation option for all throughput ranges.

Embedding QuantiFERON assays in the broad assay menu of DiaSorin’s LIAISON analyzers also gives current LIAISON customers an attractive new assay option with significant growth potential. The workflow pairs QIAGEN’s standard QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT, containing the core QuantiFERON technology) with DiaSorin’s newly launched LIAISON QuantiFERON-TB Plus detection assay. More than 8,000 LIAISON systems have been placed worldwide, primarily in hospital laboratories.

“We are pleased to announce FDA approval of the LIAISON QuantiFERON-TB Gold Plus Test for use on the LIAISON platform and the broad-based initiation of our launch for this new automation option in the United States. The validation of the QuantiFERON technology with the LIAISON platforms further reinforced the clinical profile of QuantiFERON-TB Gold Plus,” said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. “QFT-Plus users are gaining access to the LIAISON’s powerful, highly flexible automation for all throughput segments, as well as to LIAISON’s broad menu of more than 100 tests. The LIAISON workflow for QFT-Plus was introduced in Europe in 2018 and is planned for China in 2020. Combined with front-end automation options for liquid handling, the LIAISON workflow for QFT-Plus delivers significant gains in turnaround time and efficiency.”

“Today we made a step further in our strategy to drive the conversion to the most advanced solution available in the market for the detection of latent tuberculosis,” Carlo Rosa, Chief Executive Officer of DiaSorin Group, commented. “LIAISON QuantiFERON-TB Gold Plus Test, already available in Europe since September 2018, is now available in the United States on the LIAISON family platforms and we believe this solution for laboratories will further strengthen our positioning as a specialty player”.

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