Co-Development of Drugs and Pharmacogenomics-Based Diagnostics in Oncology

The molecular diagnostic industry continues to grow at a double-digit pace to meet increasing demand for the integration of diagnostic procedures with the selection of therapy, and the development of personalized drugs whose administration is guided by test results. Newly developed anticancer drugs are targeted to tumor-specific gene and protein signatures that may ultimately require co-approval of diagnostic and therapeutic products by the regulatory agencies. At the same time, an increasingly educated public using the Internet and other resources are demanding more and more information about their specific forms of cancer and how they might be arrested or cured with new therapies custom-designed for their individual clinical status. To respond to this demand, major pharmaceutical companies will either partner with diagnostics companies or develop their own in-house capabilities allowing them to efficiently produce more effective and less toxic integrated personalized medicine “drug and test ” products. For diagnostic laboratories, surgical pathologists, functional imagers, and oncologists, this integration of diagnostics and therapeutics represents a major new opportunity to further advance cancer care as a paradigm of the new medicine based on the use of test results for drug selection, dosage, route of administration, and multidrug combinations.