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Qiagen, DiaSorin Obtain FDA Approval for Latent TB Test on Benchtop Platform

NEW YORK ─ Qiagen and DiaSorin on Monday announced that the US Food and Drug Administration has approved the Liaison QuantiFeron-TB Gold Plus assay for latent tuberculosis testing on DiaSorin’s Liaison XS benchtop platform.

The Liaison QuantiFeron-TB Gold Plus interferon-gamma release assay developed by Qiagen, based in Hilden, Germany, and DiaSorin, based in Saluggia, Italy, tests for interferon-gamma released from T cells that have encountered TB bacteria.

The new premarket approval broadens accessibility in the US to a highly automated workflow for latent TB testing using Qiagen's QuantiFeron blood-based assay and follows an FDA approval in 2019 for the assay running on DiaSorin’s higher-throughput Liaison XL analyzer, the firms said.

The new approval also expands the range of potential customers for latent TB testing to include smaller healthcare clinics alongside those at larger hospitals, medical centers, and reference laboratories, the firms said.

"The addition of the Liaison XS platform will open up new joint opportunities for us to reach new customer segments requiring lower-throughput options," Thierry Bernard, CEO of Qiagen, said in a statement.

The firms said they will cooperate closely on the promotion and sale of their joint products for TB testing.