Agilent Receives European IVDR Class C Certification for GenetiSure Dx Postnatal Assay
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Insights
The receipt of the European IVDR Class C certification by Agilent Technologies for its GenetiSure Dx Postnatal Assay is a significant milestone within the medical diagnostics sector. This recent development is indicative of the assay's compliance with stringent European regulations that aim to safeguard diagnostic accuracy and patient safety. The GenetiSure Dx Postnatal Assay is a pivotal tool for clinical geneticists due to its ability to detect chromosomal abnormalities that contribute to various developmental conditions.
The IVDR Class C certification is not merely a regulatory hurdle; it is a testament to the product's reliability and quality, potentially influencing procurement decisions of healthcare providers within the European Union. The in vitro diagnostics market is notably competitive and regulatory certifications can offer a competitive edge, leading to potential market share gains and favorable investor perception. Furthermore, the assay's integration into a complete workflow system underscores Agilent’s commitment to providing comprehensive solutions, which could translate to increased customer loyalty and long-term sales growth.
Agilent's announcement can be expected to resonate with investors due to the essential role in vitro diagnostic devices play in medical decision-making. By ensuring the continued availability of the GenetiSure Dx Postnatal Assay in the EU market, Agilent not only fortifies its product offerings but also aligns itself with the prevalent regulatory landscape, effectively mitigating the risk of market withdrawal or legal complications. Given that diagnostic devices influence an estimated 70% of all diagnostic decisions, this certification secures the product’s placement within a critical segment of healthcare services.
From an industry perspective, the alignment with IVDR requirements may pave the way for a smoother introduction of future Agilent products into the European market, thereby supporting the company's long-term strategic positioning. The emphasis on comprehensive diagnostics, including postnatal testing, is a growing market and Agilent's certification could signal its readiness to meet increasing demand, particularly in light of the growing emphasis on personalized medicine and genetic diagnostics.
In vitro diagnostic devices, which include pregnancy tests, COVID-19 tests, urine test strips, and more, are estimated to play a part in
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 with a firmly established track record of diagnostic accuracy and ease of use.
Bob McMahon, interim president of Agilent’s Diagnostics and Genomics Group, commented on this announcement. “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.”
Jenipher Dalton, chief quality and regulatory officer at Agilent, summarized the announcement’s significance. “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.”
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.
1. In Vitro Diagnostic Medical Devices Regulation (europa.eu)
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of
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Naomi Goumillout
Agilent Technologies
+1.978.314.1862
naomi.goumillout@agilent.com
Source: Agilent Technologies Inc.
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