PREDICTION-ADR · Personalisation of tREatment In Cardiovascular disease through next generation sequencing in Adverse Drug Reactions

Prediction-ADR aims to discover the genetic factors predisposing patients to adverse drug reactions (ADRs) from cardiovascular disease (CVD) drugs. This will be achieved by assembling a consented blood bank and DNA for a population of ~500 cases of ACEi induced angioedema and statin induced myopathy defined using a standardised phenotypic criteria. An innovative next generation sequencing strategy will be used to find predisposing genetic changes to myopathy and angioedema. Our SME partner will use proprietary software to build a highly predictive genetic algorithm for subsequent performance evaluation in real world clinical datasets involving >50,000 patients. This will deliver a novel set of genomic biomarkers to improve effective prevention or treatment of CVD providing the EU SME competitive advantage in the emerging personalised medicine market. The number of CVD drug prescriptions globally means that the absolute number of adverse drug reactions (ADRs) is substantial resulting in harm to the patients and leading to discontinuation and increased risk of CVD progression. Genome wide association studies (GWAS) has recently accelerated the progress in determining genetic biomarkers for adverse responses to drugs and with the advent of affordable whole genome sequencing, genetic research is now positioned to accelerating it even further. This provides a new opportunity to discover improved genomic biomarkers for extreme phenotypes of severe ADRs. The ultimate goal is to have these markers accepted by EMA and FDA and to disseminate these findings not only to the scientific community but also to lay people and patient organisations. This genetic algorithm will be developed into a commercially available clinical test by Asper Biotech. As 7 Million individuals were treated with statins in the UK alone during 2012, the size of the potential market for this test is immense.