Laboratory Industry Report

The FDA’s concern over LabCorp’s marketing of its OvaSure ovarian cancer test appears to be intensifying. In a letter dated September 29, Steven Gutman, the FDA’s director of the Office of In Vitro Diagnostic Device Evaluation and Safety, warned CEO David P. King that the agency had conducted a review of the marketing and technical information available for the tests and concluded that there are "serious regulatory problems involving this device," and that regulatory action would be initiated if the premarket approval was not initiated to correct violations.