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In Diagnostics, Is FDA Approval Superfluous?

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.

At breakfast one morning in March, a top executive of a small biotech company contemplating a move into clinical diagnostics said one key dilemma the company faces is whether to go for FDA approval of its proposed assays. The expected sales boost from an FDA approval doesn't always materialize, he noted, particularly as more home brews—diagnostic tests that don't go through the process because they are developed by the laboratories that run them—become available.

The proliferation of non-FDA approved clinical diagnostic tests isn't new. But what's striking about this executive's comments is the extent...

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