一種新型分析儀器能夠用于分析體外診斷基因芯片，是第一種獲得美國食品藥品管理局許可用于IVD的產(chǎn)品，為核酸診斷提供了標準平臺。

這種分析儀叫做GeneChip系統(tǒng)3000Dx (GCS 3000Dx)，是由Affymetrix公司研制開發(fā)的。該公司指出FDA的許可代表了基因芯片臨床應(yīng)用的重大進展。基因芯片分析揭示詳細分子生物學(xué)信息，幫助臨床工作人員進行更加精確的診斷以及采用更經(jīng)濟的治療方法。

Affymetrix公司主席兼首席執(zhí)行官Stephe P.A.Fodor博士說：“FDA的決定是Affymetrix公司進軍臨床診斷產(chǎn)品的里程碑?！?/P>

在2004年8月，這種分析儀以及Affymetrix公司的制造設(shè)備獲得了ISO認證，在9月這套分析系統(tǒng)獲得了IVD CE標志。Affymetrix致力于公司的“Powered by Affymetrix”合作伙伴進行基因型檢測，并使用GCS3000D系統(tǒng)進行基因表達的診斷分析。
 
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.