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In Diagnostics, Is FDA Approval Superfluous?

Executive Summary

The proliferation of non-FDA approved clinical diagnostic tests isn't new. But the extent to which bypassing the FDA has become the norm is striking, particularly for new molecular tests. The non-approved tests appear to have good quality and comparable levels of reimbursement to FDA-approved tests, and are cheaper for laboratories. No one in government or elsewhere is forcing laboratories to use the approved tests once they're available. So, many in the diagnostics industry, especially those involved in emerging technologies, are questioning the value of going through the FDA.

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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.

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 Murky Regulatory Arena of Genetic Testing

The FDA has undertaken several measures to make the regulatory process less burdensome for diagnostics companies, but these may not be enough to incentivize companies to take their new genetic tests through the approval process. At the same time, confusion reigns: a special HHS advisory committee on genetic testing has been disbanded, and the FDA is reviewing its jurisdiction to regulate home brews, which are the dominant route to commercialization for genetic tests. Some critics worry that these developments may stifle innovation and companies are waiting for clarity.

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