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"Not An IVDMIA"

This article was originally published in The Gray Sheet

Executive Summary

It pays to look with some caution nowadays when a company announces plans to launch its gene-based test as a service out of a clinical laboratory without need for FDA go-ahead. Although this has been a tried and true method for getting new assays on the market since the inception of the Clinical Laboratory Improvement Amendments of 1988, FDA has been sharpening its focus on certain laboratory-developed tests, or home brews, in recent years. It's in the midst of developing the in vitro diagnostic multivariate index assay policy, where a certain segment of more complex lab-developed test services will be required to go through FDA review. And, recently, the agency took the Laboratory Corporation of America to task in a warning letter targeting the OvaSure ovarian cancer home brew ("The Gray Sheet" Oct. 27, 2008, p. 10).
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