Qiagen and DiaSorin announced that the US Food and Drug Administration (FDA) has approved the Liaison QuantiFERON-TB Gold Plus assay for use on DiaSorin’s automated Liaison XS platform.

The approval widens the accessibility of US customers to automation solutions for processing Qiagen’s leading blood-based test for latent tuberculosis (TB) detection and support the conversion from the traditional tuberculin skin tests that were developed over a century ago.

The highly automated workflow on Liaison platforms gives QuantiFERON customers a powerful, flexible automated option for all throughput ranges. The addition of the fully automated Liaison XS platform to the already approved use of this assay on the Liaison XL version expands the range of potential customers to include experts at smaller healthcare clinics alongside those at larger hospitals and medical centers and reference laboratories.

“QuantiFERON-TB Gold Plus continues to set new standards in the global fight against TB, a disease that remains a persistent killer and impacts people around the world,” said Thierry Bernard, CEO of Qiagen N.V. “Our partnership with DiaSorin has enabled customers to absorb the increasing demand for TB detection with access to a proven automation solution on the Liaison XL platform, especially in larger reference labs and hospitals. The addition of the Liaison XS platform will open up new joint opportunities for us to reach new customer segments requiring lower-throughput options.”

Carlo Rosa, CEO of DiaSorin Group, commented: “Today we announce the approval of our first PMA assay available on the Liaison XS platform. This solution is a key milestone of our Liaison XS strategy in the US, where the test was already successfully launched in 2019 on our Liaison XL platform. Making this test available with our partner Qiagen for use on the Liaison XS benchtop solution is part of our plan to increase adoption of this highly automated solution on a platform that is suitable for smaller-size laboratories.”

Liaison QuantiFERON-TB Gold Plus is an interferon-gamma release assay (IGRA) developed by Qiagen and DiaSorin to offer streamlined laboratory automation for latent TB screening. QuantiFERON-TB – which tests for interferon-gamma released from T-cells that have encountered TB bacteria – has been available on Liaison XL platforms in the US since 2019.

Qiagen and DiaSorin will continue to cooperate closely on the promotion and sale of their joint solutions for TB testing to make sure their customers reap the full benefit of their collaboration.

TB is one of the biggest global healthcare problems. About one third of the world’s population is estimated by the World Health Organization (WHO) to carry the infection in its latent form – about 2.5 billion people. Left untreated, up to 10% of them will become active TB sufferers. The disease is one of world’s top 10 causes of death, claiming around 1.7 million victims each year.

The highly contagious bacterial infection is spread primarily through coughing by patients with the active, lung-based form of the disease. But the bacterium can also cause infection without disease symptoms, a condition known as latent tuberculosis (LTBI). As part of programs to eradicate TB, the WHO and other international organizations have expanded guidelines for screening high-risk individuals and treating those with LTBI to help prevent further contagion.

Qiagen N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life.

Headquartered in Italy and listed at the Italian Stock Exchange in the FTSE MIB Index, DiaSorin is a global leader in the In Vitro Diagnostic (IVD) field and is active since 2021 in the life science business.