NEW YORK (360Dx) – Qiagen and DiaSorin said today that they are working together to develop an ultra-sensitive in vitro diagnostic test for Lyme disease that combines Qiagen's QuantiFeron (interferon-gamma release assay) technology with DiaSorin's Liaison automated analyzers.
The companies noted that the QuantiFeron technology has two components: a sample collection component featuring proprietary assay stimulus and initiation; and a readout component that measures the signal created by this stimulus. The readout component will be run on DiaSorin's Liaison analyzers, of which more than 8,000 are installed globally, and both components will be designed for use on the platform.
In addition, the companies plan to market the assay for use alongside DiaSorin's existing Lyme disease tests, Liaison Borrelia IgG and IgM.
Qiagen and DiaSorin plan to run multi-site clinical validations during the 2020 Lyme disease season and to file regulatory submissions later that year in the US and Europe.
"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 underdiagnosed infection afflicting hundreds of thousands of patients a year," Thierry Bernard, senior vice president and head of the molecular diagnostics business area at Qiagen, said in a statement. "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."
Qiagen and DiaSorin already have a partnership in place to automate QuantiFeron-based tuberculosis testing on Liaison analyzers. The companies have launched the fully automated workflow in Europe, and are planning for a similar launch in the US in 2019 and China in the future.