If you are using or recommending this test, this might be of interest with the latest FDA action until it is determined if the the specifications meet the specifications as developed at Yale. BD
The FDA has warned clinical-test giant LabCorp that it has been marketing an ovarian cancer test without approval, vindicating skeptics of the assay who worried it wasn’t ready for prime time. 
OvaSure, developed by researchers at Yale, measures six proteins in blood samples and calculates the chances that a woman has ovarian cancer.
LabCorp made the $220 test available in June, without prior FDA review, by taking advantage of a technicality. The regulator doesn’t require a premarket review for tests developed and performed by a single lab.
But in a letter dated Sept. 29 and released today, the FDA determined that because the test was developed at Yale and that parts of it were manufactured elsewhere to the university’s specifications, it must meet the agency’s usual premarketing approval requirements, which could take up a year.
http://blogs.wsj.com/health/2008/10/08/fda-slams-labcorp-for-selling-unapproved-ovarian-cancer-test/
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