Urine test could save industry money
toxic effects of new drugs potentially making clinical trials
safer, more effective, and saving the industry millions of euros.
New statistical technology developed by UK company BlueGnome and funded by the Wellcome Trust medical charity, should for the first time provide a means of identifying potentially toxic patterns of metabolites in urine which are closely correlated with genetic changes in the liver.
This could help pharmaceutical companies make clinical trials safer and less expensive by enabling the rapid identification of patients with toxic reactions, according to the Wellcome Trust.
Nick Haan, BlueGnome's chief executive, said clinical trials of new drugs both high cost and high risk. "High cost due to the number of people and the amount of regulation involved and high risk because pharmaceutical companies are forced to select the one drug that is most likely to clear the huge regulatory hurdles that lie between a billion dollar blockbuster and a share price sapping failure."
The company's BlueFuse data fusion technology has already been applied in a commercial product aimed at enabling researchers to automatically identify the presence or absence of genes and proteins with a higher level of confidence than is currently possible by eliminating 'noise' generated in microarray experiments.
The idea of this product, which uses a method known as Bayesian statistics to sort through data, is to avoid a situation where promising biological targets are discarded because they do not generate a strong enough signal to rise above the background noise.
The latest development could ultimately be used in personalised medicine to determine appropriate dosages, and which drugs will be most successful for an individual given their genetic make up
Giving an idea of the scale of the savings to be had from increasing the success rate of clinical trials, data from the Tufts Centre for the Study of Drug Development (CSDD) notes that a hike from one in five to one in three successes would save an estimated $242 million (€199m).
The Wellcome Trust and Cambridge University in the UK are contributing £250,000 (€375,000) to the new project. Dr Ted Bianco, director of technology transfer at the Wellcome Trust, said: "Our goal is to nurture the latest technologies until they will have an impact on human health. This project fits the bill nicely."
