Affymetrix公司推出IVD基因芯片分析系统

一种新型分析仪器能够用于分析体外诊断基因芯片，是第一种获得美国食品药品管理局许可用于IVD的产品，为核酸诊断提供了标准平台。

这种分析仪叫做GeneChip系统3000Dx (GCS 3000Dx)，是由Affymetrix公司研制开发的。该公司指出FDA的许可代表了基因芯片临床应用的重大进展。基因芯片分析揭示详细分子生物学信息，帮助临床工作人员进行更加精确的诊断以及采用更经济的治疗方法。

Affymetrix公司主席兼首席执行官Stephe P.A.Fodor博士说：“FDA的决定是Affymetrix公司进军临床诊断产品的里程碑。”

在2004年8月，这种分析仪以及Affymetrix公司的制造设备获得了ISO认证，在9月这套分析系统获得了IVD CE标志。Affymetrix致力于公司的“Powered by Affymetrix”合作伙伴进行基因型检测，并使用GCS3000D系统进行基因表达的诊断分析。
 
System to Analyze IVD Microarrays 
 
A new instrumentation system analyzes in vitro diagnostic (IVD) microarrays and is the first microarray system to be cleared by the U.S. 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.