Professor Anne Dickinson from the Institute of Cellular Medicine recently presented the technology at an In-Vitro Testing Industrial Platform (IVTIP) conference in Brussels, whereby she explained that the test uses real human skin and immune cells to show a reaction such as a rash or blistering indicating a wider immune response within the body.
According to Dickinson, 'Skimune' is accurate and faster than anything currently on the market, ultimately saving companies time and resources.
"This skin assay offers an accurate and rapid alternative to animal testing and provides the bridge between the laboratory tests for novel drugs and the first stage of clinical trials in human. It identifies drugs or products which are likely to cause a reaction or just not work effectively in humans."
'First of its kind' for the industry
The test has been developed from a skin explant model for predicting a potentially serious complication of bone marrow transplantation, 'graft versus host' disease - a common complication following the transplant and provides a histology skin damage read out enabling the severity and potency of reaction to be gauged.
Using cells isolated from blood samples from a range of healthy volunteers and differentiated into dendritic cells which activate the T-cells, these in turn create a cytokine storm. Useful for fighting infection, if this immune response goes unchecked it can be extremely harmful to the individual.
Professor Dickinson who has spent 20 years working to understand how to prevent the body rejecting donor tissue such as bone marrow says "we've already shown this works as a way of testing new drugs for adverse immune reactions that can't be identified when tested in animal models."
'This test would have saved lives'
According to Dickinson this test would also have predicted the terrible outcome at Northwick Park in 2006. Then, six men taking part in a clinical trial had severe reactions to a monoclonal antibody resulting in organ failure.
"Previous laboratory and animal research gave no indication that this was likely to occur. Our test would have picked up the risk because it is a skin-based model of the human immune response."
The Newcastle team are also said to be working with the National Institute of Biological Standards and Control (NIBSC) to test monoclonal antibodies for adverse responses.