Heathcare Megatends III - Personalized Medicine in Cancer Therapy

Targeted cancer therapies is a $30 billion/year industry and is expected to skyrocket over the next 3-5 years as more compounds are approved and traditional one-sized-fits-all chemotherapeutic agents fall by the wayside. The DNA of cancer tumors and their proteomic makeup can vary significantly from patient to patient and ---it is now recognized --- can vary from a primary tumor to a metastatic lesion in the same patient. Molecular diagnostics (MDx) is growing in parallel with the use of targeted drugs and is a gatekeeper as to which drugs are prescribed and what the outcomes are likely to be. Predictive tests are being co-developed with these therapies in order to determine in advance how likely a patient is to respond to a certain drug. Molecular Diagnostics Over the past thirty years, total national spending on healthcare has more than doubled as a share of the gross national product. The reasons for the especially high cost of healthcare in the U.S. include the fact that most of these treatments were developed based on their usefulness in an average diseased population, each specific drug only has approximately a 50% chance of being effective for each patient. Therefore, even today patients are not always receiving the most effective and cost-efficient treatments. Since the mapping of the human genome was completed, innovative molecular diagnostic technologies and tests have emerged, based on a better understanding of the role that genes and proteins play in disease progression and response to therapy.

For all the original hoopla about genes it is now recognized that proteins spawned by genes are often the molecular bucket brigades that do most of the work in normal and diseased states. Mutated or dysregulated genes might cause proteins to be abnormally expressed, modified and/or activated, leading to many diseases including autoimmune, metabolic diseases and cancer. Cancer molecular diagnostics in particular is the fastest growing sector, which now represents a U.S. market of $1.35 billion by 2010. MDx is now encompassing the entire disease management cycle, from predisposition determination, pre-symptomatic disease detection and identification, to screening, diagnosis, drug response prediction and prognosis, monitoring treatment effectiveness and relapse prediction & management. The field of medicine is shifting toward personalized and targeted treatments. The first generation of molecular diagnostics were single-analyte tests, detecting a single gene or protein. Roche’s widely used and publicized HercepTest detects the presence of the Her2+ protein alone. The emerging second- generation of products utilizes multiplex platforms such as DNA and protein microarrays, analyzing multiple biomarkers at once. Third generation molecular diagnostics will quantitatively analyze multiple analytes to form a clearer portrait of disease through the systems biology perspective and directly apply this information towards multiple treatment selection. The goal is to allow pharmaceutical developers to accurately assess the effectiveness of their proprietary drugs and allow physicians to tailor optimized, personalized therapies to their patients.