FDA Letter Raises Specter of Premarket Approval Delay for Correlogic s Software | GenomeWeb

In 2002, Correlogic Systems nudged bioinformatics toward the clinical realm by licensing its proteomics analysis software to two commercial laboratories for development of an ovarian cancer diagnostic test. But a recent letter from the US Food and Drug Administration indicates that Correlogic — and other companies hoping to develop bioinformatics-driven diagnostic methods — may have to jump through a few more regulatory hoops than originally expected to bring such a test to market.

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