One change made by Labcorp is that OvaSure™ test cannot be used by a woman who has had both ovaries removed, ok now isn't this a given, why would a woman have this test who has no ovaries?
The test is known as what is called a “home brew” test, which the FDA has not chosen in the past to regulate, but perhaps things are changing. With the "home brew" category, labs are assumed to be responsible enough to manufacture and use them in house. Enter the world of genomics today and personalized medicine, and things are changing in the way the processes are created, thus perhaps there could be additional FDA intervention in some of these areas. BD
The U.S. Food and Drug Administration (FDA) sent a letter to the Laboratory Corporation of America (LabCorp) on August 7, 2008, stating that it believes the Yale ovarian cancer early detection test (marketed by LabCorp under the name OvaSure™) “… has not received adequate clinical validation, and may harm the public health.” In the letter, the FDA invites LabCorp to discuss all validation studies that support the marketing of the OvaSure™ test. The August 7 FDA letter appears to reflect a previously announced, yet controversial, change in FDA policy. Libby’s H*O*P*E*™ reported previously on the development of the Yale ovarian cancer early detection test [March 14, 2008], and LabCorp’s subsequent market release of that test under the name OvaSure™ [June 23, 2008].
Hat Tip: Interact MD
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