Epistem's extensive knowledge of epithelial biology has been translated into a unique hair biomarker platform. Epistem's plucked hair assay can be used to determine the effects of novel therapeutic agent exposure on protein and gene expression in hair, providing valuable pre-clinical proof of concept data. Proprietary techniques have been combined with in-house expertise to provide a highly sensitive and powerful platform to support both pre-clinical and clinical phases of the drug discovery and development pipeline. Hair is an ideal surrogate tissue to monitor drug response and is easy to sample, with good patient compliance and few ethical issues. Multiple, independent samples can be collected over the course of a clinical study with minimal discomfort and inconvenience to the patient.
Hair expression profiling can assist drug development programs in the following areas:
- Monitoring pharmacodynamic response to treatment
- Duration of drug effect
- Dose response
- Confirmation of mechanism of action
- Patient stratification
- Hair growth
Profiling of hairs is possible from both rodents and humans during pre-clinical and clinical studies. In humans the scalp is the preferred source of plucked hair as most hairs in this region are in the anagen (active growth) phase of the hair cycle.
Using our extensive database containing gene expression profiling information from mouse, rat and human samples we can confirm if genes of interest are expressed in hair.
Biomarker identification, validation and screening
Profiling of hairs is possible using Epistem's proprietary gene expression technologies.
Ex vivo hair culture
Hair plucked from healthy normal volunteers is incubated in culture, allowing us to establish drug related changes in gene expression which can guide selection of clinical biomarkers.
Epistem has developed techniques for reliable and reproducible immunohistochemistry labelling of single plucked human hairs for a number of antigens.