Agilent Technologies has received Class C Certification under the European Union In Vitro Diagnostic Regulation (IVDR) for its GenetiSure Dx Postnatal Assay.
The genomic hybridisation (CGH) assay was previously CE marked under the In Vitro Diagnostic Directive (IVDD). It now aligns with the new IVDR, which has replaced the IVDD in the EU.
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Under the new rules, in vitro diagnostic devices are subject to more stringent regulatory inspection to ensure rigorous standards of clinical evidence are met, with greater transparency and tighter standardisation.
The GenetiSure Dx Postnatal Assay device helps clinical geneticists detect genetic anomalies earlier and more accurately than traditional methods. The assay is designed to detect various anomalies, which are related to developmental delay, intellectual disability, autism, congenital irregularities and dysmorphic features in children and adults.
The assay employs Agilent’s specialised Comparative Genomic Hybridization (aCGH) technology to pinpoint genetic alterations throughout the genome, aiding cytogeneticists in precise anomaly detection. It relies on chromosomal microarray tech known for its diagnostic precision and user-friendliness.
In-vitro diagnostics (IVDs) are essential healthcare resources used to inform around 70% of all clinical decisions through the detection of disease and the monitoring of a patient’s condition or overall health, as per the 15 April announcement.
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By GlobalDataIn the announcement accompanying the certification, Agilent’s interim president Bob McMahon said: “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.
“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.”
In January 2023, Agilent joined forces with Akoya to develop multiplex-immunohistochemistry diagnostic products for tissue analysis, including spatial analysis for companies that develop precision therapeutics for cancer.
Another company in the in-vitro diagnostics space is US-based diagnostic information service provider Quest, which unveiled its consumer-focused genetic test Genetic Insights in July 2023, to assess the risk for inheritable health conditions such as breast and colon cancer.
