FDA to seller of ovarian-cancer test: You need permission
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The marketer of a test for ovarian cancer doesn’t actually have approval to sell the product, the Food and Drug Administration told the company late last month.
In a letter dated Sept. 29, the company, Laboratory Corp. of America Holdings, was told it was violating a law requiring marketing clearance for devices used in the diagnosis of diseases or other conditions before they’re offered for sale.
The director of the FDA’s Center for Devices and Radiological Health went on to explain the whys of the alleged violation in more detail. The letter then said in part:
‘Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.’
Ovarian cancer is difficult to diagnose in its early stages -- and difficult to cure in its later stages. A recent Associated Press story explains the context for this latest action: Hope, confusion surround quest for early ovarian cancer tests.
-- Tami Dennis