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Agilent Technologies Gains IVDR Class C Certification for Chromosomal Abnormality Test

NEW YORK – Agilent Technologies said on Monday that it has received IVDR Class C certification for a comparative genomic hybridization assay that is used to assess genetic anomalies that are associated with developmental delay, intellectual disability, congenital abnormalities, and dysmorphic features.

The Santa Clara, California-based firm's GenetiSure Dx Postnatal Assay uses the firm's proprietary array Comparative Genomic Hybridization technology for the qualitative determination of copy number and copy-neutral changes. The assay is based on chromosomal microarray technology, and it is designed for use on the company's SureScan Dx Microarray Scanner system with analysis through its CytoDx software.

Most molecular devices are regulated under Class C of Europe's In Vitro Diagnostic Regulation. Class C covers in vitro diagnostic devices that represent a medium to high risk to the general population but lesser risk than Class D devices. Agilent previously launched the assay in the United States and Japan.

"The GenetiSure Dx Postnatal Assay will advance the postnatal diagnosis of chromosomal abnormalities as it combines high resolution, accuracy, and speed in a single test," Bob McMahon, Agilent CFO and interim president of the company's Diagnostics and Genomics Group, said in a statement.