FDA Says CMDX Can Sell Its CGH Test Without Further Approval; Other Tests Will Face Scrutiny | GenomeWeb
CombiMatrix last week received a letter from the US Food and Drug Administration’s Office of In Vitro Diagnostics stating that the Constitutional Genetic Analysis Test sold through its CombiMatrix Molecular Diagnostics subsidiary will not require further evaluation from the agency in light of a draft guidance document on multivariate index assays FDA issued in September.
 

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