System to Analyze IVD Microarrays

Food and Drug Administration (FDA) for IVD use, providing a standardized platform for nucleic acid diagnostics.

Called the GeneChip system 3000Dx (GCS 3000Dx), the instrument was developed by Affymetrix (Santa Clara, CA, USA). The company notes that the FDA clearance represents a major step toward the use of microarrays for clinical applications. The microarray reveals a detailed molecular snapshot that should provide clinicians with more-accurate diagnoses and allow for more-effective treatment.

"The FDA's decision is another milestone demonstrating Affymetrix' commitment to clinical diagnostic products,” commented Stephen P.A. Fodor, Ph.D., chairman and CEO of Affymetrix.

In August 2004, the instrument and array manufacturing facilities of Affymetrix received ISO certification and in September, the instrument system received the IVD CE Mark. Affymetrix works with its "Powered by Affymetrix” partners to develop genotyping and gene expression diagnostics on the GCS 3000Dx system.




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