DiscoverPrint^® –A tool for the development of companion diagnostics in clinical trials of oncology therapeutics for the biotechnology and pharmaceutical industry

The importance of conduting focused, time- and cost-efficient clinical trials is crucial if potential new drugs are to be given the best possible chance of reaching the market. One of the biggest challenges in drug development, particularly in targeted oncology therapeutics, is to understand the differences in patient response rates. There have been many instances where novel therapeutics elicited a favorable response in some patients, while others showed no response.

In undifferentiated patient pools, the percentage of individuals that respond to a particular treatment is often too small to satisfy the trial's criteria. As a result, the drug is classified as a failure, potentially depriving others from potentially beneficial treatment and resulting in significant financial implications for the company.

But how will regulatory bodies view companion diagnostics? The development of companion diagnostics should not impair the launch of a therapeutic agent. It is crucial that the companion diagnostic test is developed to the highest scientific and regulatory requirements in an experienced clinical laboratory and that the test is clinically available and FDA-approved at the time of the drug launch.

• Improve efficacy of clinical trials by incorporating gene expression profiling
  -  Find new gene expression profiles for drug response and resistance
  -  Help to confirm the patient population most likely to respond to the new drug
  
  
• Reduce length of clinical trials
  -  Pre-select high risk patients with early relapses to enrich the trial for early events
  
  
• Decrease development costs
  -  Increased trial efficiency, recruiting fewer patients with shorter trial times all contribute to lowered clinical development costs