FDA Approves Wider Access to Automated Blood Test for Latent Tuberculosis

Officials with the FDA have approved the QuantiFERON-TB Gold Plus assay for use on DiaSorin’s automated LIAISON XS platform, according to a press release from Qiagen. This assay is an automated blood-based test for detecting latent tuberculosis (TB).

LIASON QuantiFERON-TB Gold Plus is an interferon-gamma release assay designed to offer streamlined laboratory automation for latent TB screening. The test searches for interferon-gamma released from T cells that have encountered TB bacteria, and it has been available on LIAISON XL platforms in the United States since 2019.

“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 NV, in a press release. “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.”

According to the World Health Organization, approximately 2.5 billion people carry TB infection in its latent form, accounting for nearly one-third of the global population. If left untreated, up to 10% of individuals with latent TB eventually become patients with active TB. The infection is primarily spread through coughing by patients with the active, lung-based form of the disease, though it can also cause infection without disease symptoms. Approximately 1.7 million individuals die from TB each year.

“Today we announce the approval of our first PMA assay available on the LIAISON XS platform,” said Carlo Rosa, CEO of DiaSorin Group, in the release. “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.”

REFERENCE

QIAGEN and DiaSorin widen access to latent TB testing in the U.S. with FDA approval of QuantiFERON®-TB Gold Plus assay on LIAISON® XS [news release]. Business Wire; November 29, 2021. Accessed November 29, 2021. https://www.businesswire.com/news/home/20211128005225/en