This article was originally published in The Gray Sheet
Executive SummaryFDA sends a warning letter to clinical lab giant Laboratory Corporation of America Sept. 29 for not obtaining clearance or approval to market its OvaSure ovarian cancer screening test, launched in June as a diagnostic service. In August, the agency had sent an "untitled" letter to LabCorp, charging the firm with marketing the test without proper clinical validation (1"The Gray Sheet" Aug. 25, 2008, p. 9). Last month, FDA officials had a face-to-face meeting with company executives. FDA typically does not enforce device review requirements for tests that are developed by a lab and offered as a service by that lab, but the warning letter points out that OvaSure was "designed, developed and validated" by Yale scientists
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