Pharma Focus Asia

Agilent Obtains U.S. FDA Approval for GenetiSure Dx Postnatal Assay

Thursday, September 14, 2017

Agilent Technologies Inc. has announced that it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the GenetiSure Dx Postnatal Assay: its first comparative genomic hybridization (CGH) assay for diagnostic use. This assay enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital irregularities, and unexplained dysmorphic features, earlier and more accurately than traditional methods.

The GenetiSure Dx Postnatal Assay is the result of an extensive clinical validation utilizing 900 samples from multiple partner laboratories and brings CGH technology into diagnostics. Based on Agilent's proprietary array for comparative genomic hybridization, this assay provides data on copy number variations and absence of heterozygosity in genomic DNA obtained from peripheral whole blood in patients who have been referred for chromosomal testing based on clinical presentation. The ability to detect both types of aberrations using a single assay provides greater diagnostic yield and faster time-to-results.

Previously available only in Europe, U.S. clinical genetic scientists can now use this assay to help identify a definitive genetic diagnosis, and rapidly change the focus of a medical investigation from finding the cause to administering appropriate medical care and family support.

"Obtaining FDA clearance of the GenetiSure Dx Postnatal Assay is a major milestone for us and solidifies Agilent’s commitment to bringing complete diagnostic solutions into routine clinical laboratories," said Kamni Vijay, vice president and general manager of Agilent’s Genomics Solutions Division and Clinical Applications Division. "By providing a validated workflow that extends from DNA to data analysis, this assay allows traditional karyotyping labs to easily adopt array-based cytogenetic testing without the high cost of extensive validation.”

This assay is intended for use on the Agilent SureScan Dx Microarray Scanner System, a Class II Exempt Medical Device, and analyzed with CytoDx Software.

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