The technology includes analyzing gene expression change in RNA extracted from the bulb of cells located at the base of a single human plucked hair. The companies have demonstrated that single plucked hairs sampled over multiple time points provide effective levels of RNA for gene expression measurement. The study also showed that the process was well tolerated by subjects and samples proved robust during shipment and storage. Over 85% of hairs sampled were evaluable for measurement. Further analysis of single hairs also established reliable detection of over 13,000 genes in single hairs, which can be used to establish ‘core gene sets’ for biomarker drug discovery, validation and patient selection.
Epistem and AstraZeneca plan to explore hair follicle core gene sets based on drug-induced gene expression in pathways of interest for specific therapeutics. Identified gene expression changes in the hair follicle will be linked to changes in tumours to determine drug exposure, toxicity and dose response leading to patient selection.
The hair biomarker is said to provide the industry with a potentially powerful tool to measure the effects of new cancer treatments and their translation from preclinical through to clinical phases, enabling more informed go/no go decisions to be undertaken at an earlier stage.