Qiagen and DiaSorin have announced the expansion of their QuantiFERON collaboration to develop an ultra-sensitive diagnostic test for Lyme disease, which is expected to address a significant unmet medical need. The companies plan multi-site clinical validations during the 2020 Lyme disease season, with regulatory submissions expected at the end of the same year in the United States and Europe. The QuantiFERON technology comes in two components: the QuantiFERON sample collection component with the proprietary assay stimulus/initiation and QuantiFERON read-out component to measure the signal created by the stimulus. The QuantiFERON read-out component of the assay will be run on DiaSorin’s widely used LIAISON family of fully automated analyzers and both components will be designed for use on these platforms.
As part of their collaborations, the two companies have already launched a fully automated workflow for the QuantiFERON-TB Gold Plus (QFT-Plus) test for latent tuberculosis (TB) infection in Europe, and are planning for launch in the United States later in 2019 and in China in the future.
SVP, Head of the Molecular Diagnostics Business Area,
“We are excited about the potential to bring the power of QuantiFERON technology to the very large unmet need in Lyme disease, a serious and under-diagnosed infection afflicting hundreds of thousands of patients a year. Early detection of the initial infection and testing for recurrence of Lyme disease are critical to protect patients from debilitating long-term effects. We believe QuantiFERON-Lyme can provide a valuable solution for these needs.”