The challenges for the implementation of molecular diagnostics in the clinical setting
Session type: Symposia
A decade ago, the publication of the first human genome marked the start of a genomic medicine era, with genetics being hailed as the holy grail of cancer diagnosis and treatment. Using molecular biomarkers to identify patients that are more likely to benefit of particular treatments, and thereby tailoring therapies for patients, was anticipated to have a major impact on clinical practice and pharmaceutical research. However, ten years later only a handful of genetic tests have been implemented into routine cancer clinical practice and such implementation has not been made swiftly across the world in many cases. This “apparent” lack of success of genomic medicine is likely the result of a combination of multiple cumulative effects including the slow implementation of technological advances in clinical practice, different scientific and clinical research agendas, regulatory and quality issues as well as practical implementation in the clinical setting. The speed at which molecular biomarker discovery is currently operating will bring answers to many scientific and clinical questions in the next few year that will allow for fine-tuning of molecular tests for the right therapies. The same technology now only available for research purposes will be made affordable and the quality improved to be used in the clinical diagnostic setting. Nonetheless, although the cost per test may be maintained or even reduced the total cost per sample is likely to be higher, and the issue of reimbursement still remains. New trials will be designed to enroll only molecularly-defined patients to increase power of the analysis with less number of patients leading to implementation of new drugs in the clinic in a timely fashion. Worldwide collaboration to design common protocols for processing and transfer of the tissue, molecular testing and clinical report could be the answer to unrestricted patient access to stratified cancer medicine.