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FDA Calls LabCorp’s Homebrew OvaSure Dx
‘High Risk,’ Says Validation ‘Inadequate’

[September 3, 2008]

By Turna Ray

The finding, disclosed in a letter the agency sent to LabCorp last month, may require the reference lab to submit the assay for regulatory approval if the FDA deems it an in vitro diagnostic multivariate index assay.

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