Diagnostics Tied to New Drugs

New data will demand new tests, and the development of new genomic tests while drugs are in trials will become increasingly important at the FDA. There are plenty of pitfalls to be expected, especially as drug makers are urged to develop genetic tests as they push a drug down the pipeline. Many experts have raised doubts that diagnostic tools can be routinely developed by Phase II or even Phase III. The more than 800 genetic tests already on the market are just a sample of what's to come, and citizens will need to be assured that any results from genetic testing will remain secret. Who wants an employer to find out if you have a 60 percent chance of developing diabetes?