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DiaSorin, Qiagen Obtain CE Mark for Lyme Disease Early Detection Test

NEW YORK – DiaSorin and Qiagen said on Wednesday that they have received CE marking for the Liaison LymeDetect assay based on QuantiFeron technology for the early diagnosis of Lyme disease.

The assay, which is now commercially available in countries accepting the CE mark, runs on the DiaSorin Liaison XL and Liaison XS automated immunochemistry testing platforms.

The assay leverages both humoral and cellular immunity through an interferon-gamma release assay stimulated by specific Lyme peptides using Qiagen's QuantiFeron LymeDetect technology, providing improved sensitivity and earlier detection of the infection than serological testing for IgG and IgM antibodies followed by western blot confirmation, the companies said.

In clinical studies, Liaison LymeDetect showed, within 21 days from the first evidence of infection, a sensitivity of up to 74 percent compared to alternative methods and a specificity of 100 percent.

The companies noted that the significantly increased sensitivity in the early stages of the disease could help physicians identify and treat the disease earlier, minimizing the risk of late and chronic manifestation, benefiting patients and reducing healthcare costs due to shorter hospitalization and long-term care for late disease treatment.

The companies began working together to develop the assay in 2019. Under the development agreement, DiaSorin is responsible for commercialization of Liaison LymeDetect, while DiaSorin and Qiagen are jointly responsible for development and production of the assay.

"The collaboration between our companies leverages [Qiagen's] QuantiFeron technology and our extensive installed base of Liaison family analyzers and is positioning us both as leaders in the T-cell response market with a unique franchise for laboratories looking for an efficient way to detect asymptomatic infections and risks that cannot be detected in all situations with standard diagnostic technologies," DiaSorin CEO Carlo Rosa said in a statement.

LymeDetect adds to Qiagen's portfolio of tests that use CD4/CD8 T-cell technology for immune response detection and infectious disease diagnosis. This portfolio included the QuantiFeron-TB Gold, or QFT, and QFT-Plus tests for latent TB, which can also be automated on DiaSorin Liaison platforms, as well as tests for SARS-CoV-2 T-cell immune response, cytomegalovirus, and transplant applications.