Over the past few years it has become increasingly clear that the classical pathways for pharmaceutical development are changing. It is an accepted fact that every individual patient is different and that a drug that works in one patient many not necessarily be equally effective in another; a drug that causes no adverse drug-related events in one patient may be toxic in another.

Similarly, there is a growing realization that enabling physicians to take a personalized approach to treatment decisions can dramatically improve clinical outcomes, reduce adverse drug related events, and improve patients' quality of life both during and after treatment. New technologies are advancing personalized medicine and enabling the pharmaceutical industry to incorporate objective testing tools in their treatment protocols to optimize treatment to individual patient needs.

Companion diagnostics (CDx) are assays or tests that help physicians determine the likelihood of the efficacy and/or safety of a specific drug when administered to an individual patient or a subgroup of patients. Co-development of companion diagnostics through partnerships between pharmaceutical and diagnostic companies can promote the development and adoption of personalized medicine for the benefit of all parties, but most importantly for the improvement of patient care.

Companion diagnostics can address a number of risks and challenges in the new drug development process. Specifically, CDx allows stratification of clinical trials to incorporate only those patients likely to respond and eliminating those who are susceptible to high levels of toxicity, leading to higher success rates, faster regulatory approval and lower development costs.

Post-marketing, CDx tools may offer opportunities to assess treatment compliance, identify growing drug resistance, and extend market exclusivity through expansion of labeling claims.

It is clear that major opportunities exist for improved patient care through partnerships between the diagnostic and pharmaceutical industries. Saladax and its MyCare™ platform is ideally suited to address these opportunities.