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CGAT |
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On October 16, 2006 we received a letter from OIVD indicating that the CGAT test need not be regulated as an In Vitro Diagnostic Multivariate Index Assay, under its recently published guidelines. The FDA has now informed CMD that it agrees that the CGAT is not an IVDMIA. CMDX' CGAT array is designed to provide a cost and time effective approach to accurately identify the specific genomic abnormality that is the cause of the clinical disorder. |
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