For the detection of biomarkers, specific tests are often required for different model organisms in order to be able to record the effects or side effects of biologically active substances (drug candidates). An antibody-based technique was linked to mass spectrometry to speed up biomarker test development and subsequent measurement. The innovative step for this analytical method lies in the design of the assay. Here, antibodies are developed that are directed against an epitope of the target analytes that is present in all relevant model organisms and in humans. This makes it easier to carry out comparisons in humans and animals.
Protein biomarkers are key factors in drug development and are used in the pre-clinical and clinical phases to assess toxicity, demonstrate efficacy and for patient stratification. To date, a number of proteins have been identified as biomarkers that indicate drug-induced organ damage to the kidney. Corresponding protein biomarkers for specific evidence of damage to the liver and cardiovascular system are currently being validated in clinical studies by publicly funded consortia from pharmaceutical companies and academic working groups.
A significant time and economic limitation in the validation of protein biomarkers and the early phase of drug development lies in the complex translation of animal experimental results to humans. In the preclinical phase, drug candidates are tested for efficacy and toxicity in various model organisms. Due to the genetic differences, however, no method exists to date to detect cross-species protein biomarkers in one assay. So far, conventional detection methods such as the sandwich immunoassay have had to be individually developed and validated for each species in time-consuming and costly processes.
With Cross Species Immunoassay Technology (XIM), we are able to determine and quantify protein biomarkers in biological samples across species in all pharma-relevant animal models and humans. The XIM technology is based on specific antibodies that bind to short peptide motifs selected with proprietary software. Protein biomarkers can be measured via these peptide motifs in all animal models relevant to drug development and in humans. After an initial immune enrichment, the biomarkers are clearly detected and quantified using an internal isotope control in a mass spectrometer.