Diasorin has secured U.S. Food and Drug Administration approval of the LIAISON QuantiFERON-TB Gold Plus II assay as a next-generation automated Interferon Gamma Release Assay (IGRA). Designed in partnership with QIAGEN N.V., the assay aims to enhance laboratory productivity, workflow efficiency, and turnaround time for latent tuberculosis infection (LTBI) testing in the United States.

The new assay enables laboratories to test up to 75% more patients per hour and achieve a 25% faster turnaround time compared to the previous version. This marks a major advance in workflow efficiency and productivity for TB diagnostics, combining Diasorin’s high-throughput LIAISON platforms with QIAGEN’s gold-standard QuantiFERON technology —giving laboratories a faster, more efficient solution to meet growing global demand for TB testing, according to the company.

LTBI affects roughly 25% of the world’s population, with up to 10% at risk of progressing to active disease if untreated. In the United States, more than 80% of tuberculosis (TB) disease cases are estimated to result from reactivation of LTBI acquired within the prior two years. Faster, scalable testing is essential to achieving World Health Organization (WHO) targets for TB elimination. The LIAISON QuantiFERON-TB Gold Plus II provides laboratories with a powerful tool to expand screening access and strengthen global TB prevention efforts.

“With more than 10 million¹ people receiving a new diagnosis of tuberculosis annually, tuberculosis continues to be a challenge in diagnosis and treatment,” said Peter Colaninno, director of Laboratory Operations at Sunrise Medical Laboratories Inc., a division of SonicHealthcare USA. “Because of its high rate of transmission, particularly in immunocompromised individuals and underserved populations, it is essential to have a diagnostic tool where a sample can be easily procured and tested. Assays performed on automated platforms, such as the Diasorin LIAISON XL, offer expedience in providing clinicians¹ CDC estimates that up to 13 million people in the United States have latent TB infection. with the vital information needed to effectively identify and treat patients with latent tuberculosis and prevent further transmission.”

Diasorin and QIAGEN have worked together since 2017 to integrate QuantiFERON technology into the LIAISON family of analyzers, combining QIAGEN’s diagnostic expertise with Diasorin’s automation expertise. More than 7,000 LIAISON XL systems are currently installed globally, enabling high-volume testing labs to process QuantiFERON-TB Gold Plus II with minimal hands-on time, full traceability, and seamless IT integration.

“With the launch of LIAISON QuantiFERON‑TB Gold Plus II in the U.S., Diasorin further strengthens its leadership in specialty diagnostics and reinforces our long‑standing partnership with QIAGEN,” Diasorin CEO Carlo Rosa stated. “This next-generation solution expands access to the world’s leading latent TB test on our LIAISON platforms, enabling laboratories worldwide to respond more effectively to rising testing needs and advancing global TB control initiatives.”

The new LIAISON QuantiFERON-TB Gold Plus II test on the LIAISON XL will be available in the United States at the end of this month following the availability in all countries that accept CE mark in November 2025.

“The U.S. regulatory approval of LIAISON QuantiFERON-TB Gold Plus II reflects our commitment, together with Diasorin, to expanding access to modern blood-based TB testing,” QIAGEN CEO Thierry Bernard stated. “We continue to invest in improving our QuantiFERON technology to support laboratories with reliable and efficient testing. Starting in 2026, we plan to introduce further evolutions to enhance performance and meet the needs of customers in the U.S. and worldwide.”

Headquartered in Italy and listed at the Italian Stock Exchange in the FTSE MIB Index, Diasorin is a global player in the in-vitro diagnostic (IVD) field and has been active since 2021 in the life sciences business. For more than 50 years, the company has been developing, producing, and marketing reagent kits used by diagnostic laboratories worldwide. The Group operates in five continents through 30 companies, four branches, 10 manufacturing facilities, and nine R&D centers.

Reference
¹ CDC estimates that up to 13 million people in the United States have latent TB infection