The Food and Drug Administration (FDA) has given 510(k) clearance to Agilent for its GenetiSure Dx Postnatal assay. Based on Agilent’s proprietary array for comparative genomic hybridization, this test detects genetic aberrations in children and adults associated with developmental delay, intellectual disabilities, congenital irregularities, and unexplained dysmorphic features. Specifically, the test provides data on copy number variations (CNV) and loss of heterozygosity (LOH) in genomic DNA obtained from peripheral whole blood, and is intended for use in patients who have been referred for chromosomal testing based on clinical presentation. Agilent clinically validated the GenetiSure Dx Postnatal assay using 900 samples from multiple partner laboratories. The test runs on the Agilent SureScan Dx Microarray Scanner system and also comes with CytoDx analysis software. This software provides a streamlined workflow for CNV and LOH data analysis and features validated algorithms that enable data suppression, classification, editing, and annotations of aberrations and report generation.
Agilent has also received two expanded FDA approvals for its cancer co-diagnostics Dako PD-L1 IHC 28-8 pharmDx and Dako PD-L1 IHC 22C3 pharmDx. The PD-L1 IHC 28-8 pharmDx test can now be used to guide therapy with Opdivo (nivolumab) in cases of urothelial carcinoma and squamous cell carcinoma of the head and neck, while the PD-L1 IHC 22C3 pharmDx test can be used to identify patients with gastric or gastroesophageal junction cancer who might benefit from treatment with Keytruda (pembrolizumab).