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., company is known, made the $220 test available in June,
under a provision that exempts tests developed and offered by a single lab from the usual
FDA review. But in a letter dated Sept. 29 and released Tuesday, the FDA determined that because the test was developed at Yale and that parts of it were manufactured elsewhere,
it must meet the agency's usual premarketing approval requirements, which could take
up to a year.
under a provision that exempts tests developed and offered by a single lab from the usual
FDA review. But in a letter dated Sept. 29 and released Tuesday, the FDA determined that because the test was developed at Yale and that parts of it were manufactured elsewhere,
it must meet the agency's usual premarketing approval requirements, which could take
up to a year.
LIVESTRONG
Dee
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