Ovarian Cancer Test Sales Are Illegal, FDA Warns

The Food and Drug Administration warned clinical test giant Laboratory Corp. of America Holdings that it was marketing an ovarian cancer test in violation of the law, vindicating skeptics of the assay who worried it wasn't ready for prime time.

OvaSure, developed by researchers at Yale School of Medicine, measures six proteins in blood samples and calculates the chances that the woman has ovarian cancer.

LabCorp, as the Burlington N.C., ... Full Story »

Posted by Kristin Gorski

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Kristin Gorski
3.8
by Kristin Gorski - Oct. 8, 2008

Relevant piece -- is the FDA becoming much more wary in its approval process and also more responsive to medical and consumer critics? I don't know much about this field, but reporting on an FDA warning to stop test sales because they are "illegal" sounds newsworthy. The reporter gets key quotations from experts and stakeholders. What's missing is the consumer's point of view.

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