There is a drive to improve health-related outcomes for patients by tailoring care to the individual. Customising healthcare, by shaping all clinical decisions and practices to individual patients, will lead to improved disease management and will also create efficiencies and cost savings by ensuring that only patients with a favourable risk-benefit profile are treated.
One way to achieve this is by the stratification of patients based on the potential of disease manifestation or response to therapy. To do this, high-confidence molecular biomarkers need to be identified. Using GenomePooling™ and Reflex™, Population Genetics can identify genetic variants in distinct populations, accurately identifying causal genetic variation that can be used to stratify patients for the likely development of disease, or response to treatment, or risk of side effects.
Using molecular biomarkers to stratify patients for a more personalised approach to therapeutic decision-making can also have significant impact on clinical trials. There is an economic need to develop the trial process so as to improve efficiency and productivity. Using high-confidence molecular biomarkers to enrich the trial population could enable new drugs to be evaluated in patients that are more likely to respond to a particular therapy or in those expected to have a reduced risk of side effects.
Taking a more personalised approach to medicine also creates an opportunity to re-evaluate drugs that have previously failed in clinical trials. In this situation, provided suitable samples were available, clinical trial populations could be retrospectively evaluated to identify patterns of genetic variation that correlated with either response or side-effect liability. These genetic variants could then be used to select patients for more focused follow-on trials providing a cost-effective opportunity to demonstrate efficacy and safety of previously unsuccessful drugs. In addition, these variants could also represent opportunities for the development of companion diagnostics for those drugs.
The ability to stratify patient populations has significant benefits for drug development. The risk of late-stage drug failures can be reduced by using clinically relevant genetic variants to identify specific individuals who will benefit from a medication, making sure that therapeutic agents are made available to those who need it. The development of companion diagnostics will also enable healthcare professionals to personalise medical management by predicting whether a drug will work in an individual and/or at what dose it should be prescribed.
