Qiagen and DiaSorin plan to conduct multi-site clinical validations of the new test during the 2020 Lyme disease season. Credit: QIAGEN.

Qiagen and DiaSorin have partnered for the development of an ultra-sensitive QuantiFERON-based diagnostic test to detect Lyme disease early.

Qiagen’s QuantiFERON technology comprises a sample collection component with the company’s assay stimulus/initiation and a read-out component to measure the signal generated by the stimulus.

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The QuantiFERON read-out component will be run on DiaSorin’s LIAISON family of fully automated analysers. Moreover, the companies intend to design both components for use on these platforms.

According to the US Centers for Disease Control (CDC) data, around 30,000 confirmed cases of Lyme disease are reported each year. However, the organisation estimates that 300,000 individuals may get the disease per year in the country.

ECDC statistics revealed nearly 35,000 confirmed cases in Europe in 2010. But many experts consider this to be significantly underestimated and expect a 100% rise in the spread of this disease during the past decade.

The existing diagnostic algorithm for the disease predicts the use of IgG and IgM detection, generated through B cell immune response, along with Western Blot as a confirmative tool.

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Qiagen noted that this approach could lead to false negatives because B cell response is not activated in early stages of the disease.

However, QuantiFERON technology will measure T cell response, which precedes B cell response and may offer better sensitivity and earlier detection of the infection.

The partners intend to develop the QuantiFERON-Lyme test for use in conjunction with LIAISON Borrelia IgG and IgM assays, risk assessment, and other medical and diagnostic evaluations.

“Early detection of the initial infection and testing for recurrence of Lyme disease are critical to protect patients from debilitating long-term effects.”

Qiagen senior vice-president and Molecular Diagnostics business area head Thierry Bernard said: “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 plan to conduct multi-site clinical validations during the 2020 Lyme disease season and submit regulatory filings in the US and Europe at the end of the same year.

Previously, the companies introduced a fully automated workflow for the QuantiFERON-TB Gold Plus (QFT-Plus) test for latent tuberculosis (TB) infection in Europe.