Qiagen and DiaSorin secure FDA approval for LIAISON QuantiFERON-TB

28 November 2019 (Last Updated November 28th, 2019 11:12)

Qiagen and DiaSorin have secured approval from the US Food and Drug Administration (FDA) for the commercial launch of LIAISON QuantiFERON-TB Gold Plus (QFT-Plus) test, which enables streamlined laboratory automation for latent tuberculosis screening.

Qiagen and DiaSorin have secured approval from the US Food and Drug Administration (FDA) for the commercial launch of LIAISON QuantiFERON-TB Gold Plus (QFT-Plus) test, which enables streamlined laboratory automation for latent tuberculosis screening.

QuantiFERON-TB Plus (QFT-Plus) is a fourth-generation modern gold standard for latent tuberculosis (TB) detection that runs on DiaSorin’s LIAISON platforms.

The approval enables shifting from tuberculin skin tests to modern blood-based QuantiFERON technology.

As a result of the automated workflow on LIAISON platforms, QuantiFERON customers can have a flexible automation option for all throughput ranges.

In 2016, 10.4 million cases of active TB across the world were reported, along with 1.7 million deaths, according to WHO estimates.

In latent TB cases, the bacterium infects a person but shows no symptoms unless the disease reaches to an active stage when it becomes highly contagious.

Over 8,000 LIAISON systems have been deployed across the world so far, primarily in hospital laboratories.

Qiagen interim CEO, senior vice president and molecular diagnostics business area head Thierry Bernard said: “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.”

In 2017, Qiagen began collaboration with DiaSorin to develop tests for DiaSorin’s LIAISON family of analysers based on QIAGEN assay technologies.

Further tests based on QuantiFERON technology are also planned to adapt to LIAISON platforms.

Through the collaborations, customers can use Hamilton Robotics Microlab STAR automated liquid handling workstation or Tecan Fluent Laboratory Automation workstation to automate the manual process of aliquoting samples from a single collection device into QuantiFERON-TB Gold Plus tubes to carry out the analysis.