GeneChip System 3000Dx

Take the proven path to market

It is the only FDA-cleared, IVDR compliant microarray system for RNA and DNA based clinical tests

Microarrays have been used to discover an impressive number of clinically informative genomic and pharmacogenomic biomarkers. However, converting promising gene signatures into clinical diagnostic or prognostic tests can be an expensive endeavor with significant development and regulatory risks.

The Genechip System 3000Dx v.2 is the foundation of the Applied Biosystems Clinical Toolkit, which includes cGMP-manufactured microarrays. The Clinical Toolkit provides a proven path to market, enabling test developers to save time and money while helping to reduce regulatory risks.

GeneChip technology has been relied upon by thousands of researchers to obtain reproducible results for all their microarray applications.

GCS 3000Dx v.2 for:

Research

Analyze or study precious human samples with confidence

Diagnostic test development

Several FDA-cleared in vitro diagnostic and IVDR compliant diagnostic tests have been developed. Many more molecular diagnostic tests are in development.

Routine testing

One system, multiple applications

One platform—multiple applications

GeneChip® System 3000Dx v.2 assay menu
Application area	RUO*	IVD**
3’ IVT expression analysis	√	√
Whole-transcript expression analysis	√	√
Genotyping/copy number	√
Cytogenetic analysis	√
Drug metabolism/pharmacogenomics	√	√
miRNA gene regulation	√
Targeted resequencing	√
Custom assays	√	√
* Each “Research Use Only” (RUO) array requires an array-specific Assay Software Module (ASM). A custom ASM can be developed for any GeneChip® Array. A Data Transfer Server (DTS) is required to export .CEL files. ** FDA-cleared, IVD or CE-marked test developed by a third-party company on the GCS 3000Dx platform.

GeneChip System 3000Dx v.2 microarray system for clinical research and molecular diagnostics

Click image to enlarge

Testimonials

"In clinical research where irreplaceable human specimens are used, you do not have a second chance. Once you use the sample, it is gone. Thus, it is highly beneficial to use IVD reagents and system with an established good analytical performance."

Catherine Dumur, PhD,
Director of the Molecular Morphology
Genomics Facility and Associate Professor at
Virginia Commonwealth University

"Affymetrix provides the tools to make it easy for Skyline to concentrate on diagnostic content. Building our AMLProfiler test on the FDA-cleared, CE-marked GCS 3000Dx v.2 microarray system using the FDA-cleared, CE-marked Gene Profiling Reagents greatly reduces our regulatory and operational risks, providing a faster path to market."

Henk Viëtor
CEO, Skyline Diagnostics BV

"The need for an FDA-cleared microarray platform was an important consideration in choosing the GCS 3000Dx system for Pathwork’s two FDA-cleared Tissue of Origin (TOO) tests, one that uses FFPE and the other frozen tumor samples."

David Craford
Chief Commercial Officer,
Pathwork Diagnostics

Specifications

GeneChip Scanner 3000Dx v.2 with AutoLoaderDx
Weight	~100 lb (45.4 kg)
Dimensions	13“ W x 22” D x 18” H (33 cm x 56 cm x 46 cm)
Loading clearance	36” (91.4 cm) above laboratory bench Additional 18“ (46 cm) in clearance for AutoloaderDx
Power	Voltage: 100–240 VAC; Current: 4–2A; Frequency: 50–60 Hz

GeneChip Fluidics Station 450Dx v.2
Weight	~80 lb (36.3 kg)
Dimensions	28“ W x 16 1/8” D x 15 13/16” H (71.1 cm x 41 cm x 40.2 cm)
Loading clearance	Additional 4“ (10.2 cm) at the back for ventilation
Power	Voltage: 100–240 VAC; Current: 3A; Power: 300 Watts

Workstation with Affymetrix Molecular Diagnostics Software (AMDS) v1.0 and higher
Weight	Computer monitor – 26 lb (11.8 kg) Computer tower – 43 lb (19.5 kg)
Dimensions	Computer monitor – 20 ¼“ W x 11” D x 21” H (52 cm x 28 cm x 54 cm) Computer tower – 6 ¾” W x 18 ½“ D x 17 2/3“ H (17 cm x 47 cm x 45 cm)
Loading clearance	36” (91.4 cm) above laboratory bench Additional 18“ (46 cm) in clearance for AutoloaderDx
Power	Voltage: 100–240 VAC