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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