Agilent Technologies announced that its GenetiSure Dx Postnatal Assay received European IVDR Class C Certification, which demonstrates that the assay meets the higher standards established by IVDR. 

The IVDR Regulatory Framework

In vitro diagnostic devices, which include pregnancy tests, COVID-19 tests, urine test strips, and more, are estimated to play a part in 70% of all diagnostic decisions.(1) The EU has introduced the IVDR regulatory framework to ensure the safety and performance of these devices. Under the new rules, in vitro diagnostic devices are subject to more stringent regulatory scrutiny to ensure rigorous standards of clinical evidence are met, with greater transparency and tighter standardization.

The GenetiSure Dx Postnatal Assay

The GenetiSure Dx Postnatal Assay uses Agilent’s proprietary array Comparative Genomic Hybridization (aCGH) to identify copy-number and copy-neutral changes across the genome, enabling cytogeneticists to accurately assess genetic anomalies associated with developmental delay, intellectual disability, congenital anomalies, and dysmorphic features. The assay is based on chromosomal microarray technology.

“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,” says Bob McMahon, interim president of Agilent’s Diagnostics and Genomics Group. “With the European IVDR Class C Certification, we are confident that this assay will continue to serve the needs of healthcare professionals and their patients across the EU.”

SureScan Dx Microarray Scanner System

The GenetiSure Dx Postnatal Assay is intended for use on the SureScan Dx Microarray Scanner system, with analysis by CytoDx software, as part of a complete “DNA-to-result” workflow. This device is not intended for standalone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or detecting or screening for acquired or somatic genetic aberrations.

“This IVDR certification attests to the safety and the quality of our products and reinforces our commitment as a provider of trusted solutions for the cytogenetics market,” says Jenipher Dalton, chief quality and regulatory officer at Agilent.

Further reading: Prenatal Diagnosis Linked to Earlier Congenital Heart Disease Surgery

References:

1. In Vitro Diagnostic Medical Devices Regulation (europa.eu)