Agilent Introduces CE-IVD Marked SureScan Dx Microarray Scanner
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Agilent Technologies Inc. has launched new SureScan Dx microarray scanner that is CE marked for in vitro diagnostic use in Europe.
The SureScan Dx microarray scanner is indicated for use in a clinical laboratory environment when measuring fluorescence signals of labeled DNA or RNA targets hybridized to microarrays used as part of a validated diagnostic assay.
The system has been validated for use with Agilent comparative genomic hybridization and gene expression microarrays.
“The Agilent SureScan Dx microarray scanner delivers high sensitivity and resolution for copy number change analysis, as well as outstanding dynamic range, providing clinician’s confidence in their microarray results,” said Frédéric Laget, vice president, Agilent’s Global Genomics Field Organization.
Laget continued, “As part of Agilent’s extensive portfolio of genomics solutions, the IVD scanner offers clinical laboratories an instrument to enable development of microarray-based assays.”
The SureScan Dx microarray scanner is CE marked in Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, and the United Kingdom.
“Agilent is the market leader in cytogenetic arrays and we are committed to bringing the best microarray solutions to a growing number of diagnostic labs and hospitals around the world,” said Heidi Kijenski, director of clinical marketing, Agilent’s Genomics Solutions Division.
Kijenski continued, “The CE-marking aligns with our overall strategy to seek regulatory clearance in key geographies, including our intention to file for 510(k) clearance in the United States.”
