Agilent Receives European IVDR Class C Certification for GenetiSure Dx Postnatal Assay
2024年4月15日 - 9:00PM
ビジネスワイヤ(英語)
Agilent Technologies Inc. (NYSE: A) today announced that its
GenetiSure Dx Postnatal Assay has received European IVDR Class C
Certification. This certification demonstrates that the assay meets
the higher standards established by IVDR. It ensures the continued
availability of this trusted qualitative assay to clinical
geneticists and other healthcare professionals throughout the
EU.
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 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 $6.83 billion in fiscal 2023 and employs approximately
18,000 people worldwide. Information about Agilent is available at
www.agilent.com. To receive the latest Agilent news, please
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version on businesswire.com: https://www.businesswire.com/news/home/20240415209169/en/
Naomi Goumillout Agilent Technologies +1.978.314.1862
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
過去 株価チャート
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Agilent Technologies (NYSE:A)
過去 株価チャート
から 6 2023 まで 6 2024