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In Pharmacogenetics, Just Do the Experiment

Hoopla and publicity greeted Roche Diagnostics's launch of the first clinical diagnostic test to predict people's reactions to certain common medications based on their genetic make up. The test, for CYP450 mutations, runs on a chip made by Affymetrix and is the first fruit of a $70 million-plus collaboration between the companies. But Roche quickly ran into a problem with the FDA, which is concerned that the test, for several reasons, isn't meeting regulatory requirements.

The FDA's recent letter to Roche Diagnostics requesting a meeting to discuss problems with the launch of the company's CYP450 microarray test highlights the uncertainty now engulfing regulations regarding unapproved genetic tests.

The letter, from Steven Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation & Safety, came in...

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