Companion diagnostics is a new approach within the drug discovery and development field and is an important step towards personalised medicine. Biomarkers are used to determine which treatment options will be effective. The list of biomarkers which provide information about drug response that have been discovered, and approved by the FDA, is constantly growing. This has encouraged pharmaceutical companies to adopt new programmes to deal with companion diagnostic products. The EpiSwitch™ technology is able to define biomarkers for use in clinical trials and for commercial companion diagnostic tests.
There are several drugs already approved or in clinical development for which specific markers have proven useful:
- Her2/neu positivity identifies breast cancer patients who are more likely to respond to trastuzumab (Herceptin).
- Oestrogen receptor or progesterone receptor expression is a prerequisite for the treatment of breast cancer with tamoxifen or aromatase inhibitors.
- The BCR-ABL translocation identifies patients with chronic myelogenous leukaemia that will respond to imatinib (Gleevec).
- Somatic mutations in the tyrosinase kinase domain of EGFR have been shown to predict a greater efficacy to gefitinib (Iressa) treatment.
This more personalised approach to medicine will require close cooperation between pharma and diagnostics firms such as OBD, with pharma responsible for driving the development. As a result, safer and more efficacious therapies will be developed and the process will be more cost-effective both for the health-care system and for the pharmaceutical companies. This would help to bring new medicines to the right patients faster than they are today.
