Molecular Diagnostics

Affymetrix offers molecular diagnostic solutions through its own CLIA-certified reference laboratory and through current Powered by Affymetrix™ partners. Affymetrix has also developed the GeneChip® System 3000Dx (GCS 3000Dx), the first microarray instrumentation system for molecular diagnostic laboratories.

Affymetrix Clinical Services Laboratory

Affymetrix Clinical Services Laboratory offers a variety of testing services through its CLIA-certified reference laboratory. Affymetrix Clinical Services Laboratory (ACSL) is an Affymetrix-owned and -operated, CLIA-certified reference laboratory that offers complex, microarray-based molecular diagnostic testing.
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Powered by Affymetrix™

The Powered by Affymetrix™ program enables commercial entities to license GeneChip® technology to develop microarray products for applications in diagnostics, forensics, animal testing, industrial testing, food testing and more. GeneChip® technology enables Powered by Affymetrix partners to develop innovative products that provide accurate and robust solutions.
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GeneChip® System 3000Dx v.2

The Affymetrix GeneChip® System 3000Dx v.2 (GCS 3000Dx v.2) is Affymetrix' second-generation solution for seamless DNA and RNA analysis.¹

The GCS 3000Dx v.2— which is 510(k) cleared and CE marked for in vitro diagnostic use— consists of the GeneChip® Scanner 3000Dx v.2, the GeneChip® Fluidics Station 450Dx v.2 and Workstation with Affymetrix Molecular Diagnostics Software (AMDS).

Figure 1: AMDS worklists can monitor all processing stages of every specimen in the course of the assay

Figure 2: The Fluidics Worklist allows eash control and monitoring of the fluidics protocols for each assay.

Key benefits of AMDS include:

• Enables assay providers to build analysis and reporting software modules to place on top of AMDS
• User-friendly interface for customers
• Diagnostics-focused user interface designed for the diagnostic lab’s workflow
• Meets regulatory requirements for a Class II Medical Device
• Provides patient data security

GCS 3000Dx v.2 enables you to run the following Affymetrix assays:

• Human Genome U133 Plus 2.0²
• Human Mapping 250K Nsp²

¹ RNA analysis is pending FDA clearance.
² Research Use Only. Not for use in diagnostic procedures.

Ordering Information:

Part No.	Description
00-0334	GeneChip® System 3000Dx v.2 GeneChip® Scanner 3000Dx v.2 with AutoLoaderDx, Fluidics Station 450Dx v.2 and Workstation with AMDS
00-0349	GCS 3000Dx v.2 with Data Transfer Server GeneChip® Scanner 3000Dx v.2 with AutoLoaderDx, Fluidics Station 450Dx v.2, Workstation with AMDS and Data Transfer Server
00-0335	GeneChip® Fluidics Station 450Dx v.2

Related Products:

Part No.	Description
90-0795	Data Transfer Server for GCS 3000Dx v.2
00-0331	GeneChip® Hybridization Oven 645

GeneChip® System 3000Dx

The GeneChip® System 3000Dx (GCS 3000Dx) is the first microarray instrumentation system for molecular diagnostic laboratories. The system consists of the Fluidics Station 450Dx, which automates hybridization, washing and staining of the array; the GCS 3000Dx Scanner with AutoLoader Dx, which allows you to load 48 microarrays to be scanned without operator intervention; and a Workstation with GCOS Dx software.

The GCS 3000Dx is 510(k)-cleared and CE-marked for in vitro diagnostic use in conjunction with the Roche Diagnostics AmpliChip CYP450 Test. The AmpliChip CYP450 Test is the first microarray-based diagnostic test and the first product to be released through the Powered by Affymetrix™ partnership between Affymetrix and Roche Diagnostics.

Read more in the GCS 3000Dx Brochure (pdf, 322 KB).

Part No.	Description
00-0151	GeneChip® System 3000Dx for European Union GCS 3000 Scanner Dx with AutoLoader, Fluidics Station 450Dx and Workstation with GCOSDx software
00-0200	GeneChip® System 3000Dx for North America GCS 3000 Scanner Dx with AutoLoader, Fluidics Station 450Dx and Workstation with GCOSDx software
00-0147	Fluidics Station 450Dx for European Union
00-0208	Fluidics Station 450Dx for North America

Learn More About

FDA clearance for gene expression diagnostic testing
Roche AmpliChip CYP450 Test
Powered by Affymetrix™ program
GeneChip® System 3000Dx press release

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The Affymetrix microarray manufacturing facility in West Sacramento, California, received ISO 13488:1996 certification in August 2004. The ISO standards were developed by the International Organization for Standardization and apply to design, manufacture, delivery and support of medical devices. These certifications have been registered by TUV of North America, our Notified Body.

Affymetrix' commitment to delivering high-quality products to our customers is reflected in these ISO certifications. Maintaining ISO certification through continual improvement is a top priority for Affymetrix, and that translates into innovative products that are reproducible, robust and accurate.