FDA Says CMDX Can Sell Its CGH Test Without Further Approval; Other Tests Will Face Scrutiny | GenomeWeb
The US Food and Drug Administration last week told CombiMatrix that it can sell its Constitutional Genetic Analysis test through its CombiMatrix Molecular Diagnostics subsidiary without any additional regulatory evaluation.
But while CombiMatrix can now freely sell the CGAT, which uses array comparative genomic hybridization to test for a variety of genetic diseases, the company is not in the clear when it comes to the handful of tests it hopes to commercialize through CMDX over the next six months.

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