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# Agilent GenetiSure Dx Postnatal Assay Cleared
- URL: https://www.fdaweb.com/agilent-genetisure-dx-postnatal-assay-cleared/
- Published: 2017-09-13T12:00:00.000Z
- Updated: 2026-09-14T22:49:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139621

FDA has cleared an Agilent Technologies 510(k) for the GenetiSure Dx Postnatal Assay, a comparative genomic hybridization assay for diagnostic use. It is intended for use in detecting genetic aberrations associated with developmental delay, intellectual disabilities, congenital irregularities, and unexplained dysmorphic features, according to the company. The 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,” Agilent says. “The ability to detect both types of aberrations using a single assay provides greater diagnostic yield and faster time-to-results.” The test is intended for use on the Agilent SureScan Dx Microarray Scanner System.