Development of a novel diagnostic assay for the detection of Lyme disease

Lyme disease (LD) or Lyme borreliosis is a vector-borne, multisystem inflammatory bacterial illness transmitted to humans by the bite of ticks (Ixodes species) carrying spirochetes of the genius Borrelia. Prior laboratory tests most widely used are serological tests that are unfortunately characterized by a poor sensitivity and specificity. These tests can sometimes provide false-positive results, and very often are not able to diagnose infected patients at an early stage, and are unable to discriminate between active and cured infection. Since serology is not optimal for the diagnosis, we developed a cell-based assay in which the previous exposure to Borrelia spirochetes is examined. Using whole blood or isolated peripheral blood mononuclear cells (PBMC) from LD patients we observed a specific pattern of cytokine production after exposure to a set of Borrelia antigens. These cytokines were strongly elevated in LD patients when compared to healthy individuals. By testing large groups of patients with LD and healthy controls we were able to develop a diagnostic assay, based on re-stimulation of immune cells with Borrelia antigens. The diagnostic assay (SpiroFind) is patented and was licensed to Boulder Diagnostics, Boulder, CO, USA in 2011. Recently, Oxford Immunotec (UK) bought Boulder Diagnostics. Oxford Immunotec has validated the assay in patients with LD, both in the USA and Europe. Currently, we are conducting a prospective study to compare the Spirofind 2.0 assay with 3 other cell-based assays for the diagnosis of LD (Victory study). The goal is to introduce the diagnostic assay (Sprirofind 2.0) to the market in 2018 or 2019.