LabCorp Halts Sales of OvaSure, Counters FDA Allegations

Laboratory Corporation of America (LabCorp) has voluntarily halted sales of its ovarian cancer-screening test even though it disagrees with a recent warning letter asserting that OvaSure is a medical device subject to FDA regulation.

“We are deeply concerned that the unprecedented position FDA has advanced in its warning letter will limit the dissemination of information and expertise, and will stifle the ability of laboratories to provide innovative diagnostic tests,” LabCorp’s Senior Vice President Samuel Eberts says in a response letter to the FDA.

SOURCE: FDA NEWS