In 2015, Innatoss initiated a pilot study (Ixodes) to longitudinally assess T-cell responses to Borrelia, the causative agent of Lyme Disease. Individuals with a recent tick bite as well as control were included and blood was collected immediately, after 4 weeks and 3 months, and analyzed for both T-cell and antibody responses. Blood was collected from these volunteers before and after they started taken antibiotics.
In 2016, based on the initial encouraging data of the Ixodes study, Innatoss started a collaborative project with academic and industrial partners from the Medical University of Vienna (Wien, Austria), DIARECT (Freiburg, Germany), and npk design (Leiden, NL) on the development of a cell-mediated immunity test for Borrelia. The ID-Lyme consortium is funded by the European commission under the Horizon 2020 Research and Innovation program. The aim of this project was to develop the first point-of-care diagnostic test that can identify Borrelia infections in the early stage prior to the onset of symptoms, to enable early and effective treatment of patients, improve quality of life of patients and reduce Lyme Borreliosis-related healthcare costs.
In total, nearly 500 individuals with a recent tick bite, 40 individuals with the characteristic bullseye rash and 140 negative controls participated in the Ixodes study. Unfortunately, analysis of the final data set showed that T-cell responses had both insufficient specificity and sensitivity to distinguish participants with and without a recent infection and thus to be of value as a diagnostic test.
The ID-Lyme consortium, therefore, put all its efforts into the technical arm of the project, which involved the design of a novel liquid handling device (termed WOLF). This device was designed to address the key logistical hurdle of cell-based immunity (CMI) tests: the fact that living cells are needed and hence blood needs to be stimulated within hours from collection. The WOLF device consists of a splitter device with an integrated blood collection tube holder and a 4-chambered cartridge that can be filled with disease-specific stimuli for CMI testing. WOLFs enables the stimulation of blood directly at the point of blood collection, without the need for specialized personnel and laboratory facilities such as biosafety cabinets. Our vision is that the availability of this novel liquid handling device will stimulate the development of novel CMI-based tests for a range of intracellular pathogens.