Pharmacogenomics and personalized medicine in clinical practice.

The Santorini Conference on prospective biology, genomics and pharmacogenomics occurs every 2 years. On 30 September to 2nd October 2010, the fifth meeting in this series took place in Santorini, Greece. This conference has established a tradition of organizing a workshop each time to address the most recent developments and key issues in pharmacogenomics. This year, the workshop was chaired by Bryan Dechairo and Alain Huriez, and was titled 'Pharmacogenomics and personalized medicine in clinical practice'.

Market access challenges in the EU for high medical value diagnostic tests.

The clinical utility and medico-economic value of several personalized diagnostic tests has been well described in the literature. Development of such tests, including generation of the necessary supportive clinical validation data, is a complex and expensive endeavor. In general, sponsors of such tests lack sufficient clarity on appropriate reimbursement and regulatory pathways to provide the clear development framework necessary to incentivize the required level of investment. In the USA, an imperfect reimbursement paradigm has evolved to accommodate a small number of 'value-priced' laboratory-developed tests, although major structural barriers remain to broader implementation. In Europe, by contrast, there is virtually no precedent for value-based public sector pricing, and even such procedurally based pricing as currently exists is administered by a complex network of largely decentralized bodies. As a consequence, patient access is limited and health-economic savings are not realized. This article explores some of the European market entry barriers, with a focus on reimbursement challenges, and highlights some collaborative proposals to address such.

Company Profile: TcLand Expression.

TcLand Expression is a fully integrated molecular diagnostics company that holds a pioneering position in personalized medicine focusing on immunology (transplantation and autoimmune disorders). The company has a well-balanced pipeline of blood-based gene-expression biomarkers and companion diagnostics in development. The company's state-of-the-art central laboratories are International Organization for Standardization (ISO) 17025-accredited for quantitative PCR. TcLand Expression has expertise in all the steps of biomarker development, from research and development, bioinformatics and biostatistics to clinical and regulatory affairs, market access and production. Through gene-set discovery, external and clinical validation in large multinational studies, TcLand Expression is developing diagnostic and prognostic blood tests to help make personalized medicine a reality for transplant recipients and patients with autoimmune diseases.