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Qiagen, DiaSorin Automated TB Test Gets FDA Clearance

NEW YORK – Qiagen and DiaSorin said on Wednesday that they have received US Food and Drug Administration approval for the Liaison QuantiFeron-TB Plus Test, an automated workflow and assay for latent tuberculosis detection.

As a result, the companies have launched the test in the US.

The workflow pairs Qiagen's standard QuantiFeron-TB Gold Plus (QFT-Plus) Blood Collection Tubes with DiaSorin's Liaison QuantiFeron-TB Plus detection assay, which runs on the DiaSorin Liaison laboratory analyzer. The QFT-Plus tubes contain key components of the test reaction that is performed in-tube after blood collection, while the QuantiFeron test measures the release of interferon gamma after in-tube incubation.

More than 8,000 Liaison systems have been placed worldwide, primarily in hospital laboratories, the companies said.

"We are pleased to announce FDA approval ... and the broad-based initiation of our launch for this new automation option in the United States," Thierry Bernard, interim CEO of Qiagen and senior vice president and head of molecular diagnostics at Qiagen, said in a statement.

"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,' Bernard added.

The Liaison workflow for QFT-Plus was introduced in Europe in 2018 with CE marking, and is planned for commercialization in China in 2020, Bernard added.