FDA Questions LabCorp On Its Ovarian Cancer Test Service
This article was originally published in The Gray Sheet
Executive Summary
FDA is charging clinical lab giant Laboratory Corporation of America with marketing a test for ovarian cancer without proper clinical validation
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LabCorp Pulls OvaSure, But Charges FDA With Overreaching
Laboratory Corporation of America pulled its early-stage ovarian cancer test service from the market last week in response to FDA scrutiny, but the lab giant called the agency's actions leading up to the withdrawal "unprecedented.
LabCorp Pulls OvaSure, But Charges FDA With Overreaching
Laboratory Corporation of America pulled its early-stage ovarian cancer test service from the market last week in response to FDA scrutiny, but the lab giant called the agency's actions leading up to the withdrawal "unprecedented.
LabCorp warning
FDA 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