Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan
December 22 2020 - 10:00PM
Business Wire
Agilent Technologies Inc. (NYSE: A) announced it has obtained
clearance from the Ministry of Health, Labour and Welfare (MHLW) in
Japan for the GenetiSure Dx Postnatal Assay – a microarray-based
assay for diagnostic use. This assay enables clinical geneticists
to detect genetic aberrations associated with developmental delay,
intellectual disabilities, congenital anomalies, and unexplained
dysmorphic features. The company also announced that it has
registered its microarray scanner, SureScan Dx Scanner, as a Class
I medical device in Japan, intended for use with the assay.
Based on Agilent's proprietary microarray for comparative
genomic hybridization (CGH), the GenetiSure Dx Postnatal Assay is a
qualitative assay for the postnatal diagnosis of copy-number
alterations (CNVs) and copy-neutral loss of heterozygosity (cnLOH)
from genomic DNA (gDNA), obtained from the peripheral whole blood
in patients who have been referred for chromosomal testing based on
clinical presentation. The GenetiSure Dx Postnatal Assay is the
result of a clinical validation utilizing 900 samples and brings
CGH technology into a diagnostic setting in Japan. Available since
2017 as an in vitro diagnostic assay (IVD) in Europe and the United
States, Japanese clinical geneticists can now have access to this
assay to help identify a definitive genetic diagnosis for their
patients.
"We are truly excited and humbled to bring the power of
diagnostic microarray testing to the Japanese market. With
clinically-proven performance and a track record of adoption in the
U.S. and European Union, this presents a compelling option to
patients, their families, and medical professionals to minimize the
diagnostic odyssey often faced in clinical genetic testing
settings,” said Kevin Meldrum, general manager and vice president
of Agilent’s Genomics Solutions Division. “Agilent is in the
process of preparing for the commercial launch of the assay in
Japan, expected to occur in the first half of 2021.”
The assay is intended to be used on the SureScan Dx Microarray
Scanner System and analyzed by CytoDx Software. This device is not
intended to be used for standalone diagnostic purposes,
pre-implantation or prenatal testing or screening, population
screening, or for the detection of, or screening for, acquired or
somatic genetic aberrations.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life
sciences, diagnostics, and applied chemical markets, delivering
insight and innovation toward improving the quality of life.
Agilent instruments, software, services, solutions, and people
provide trusted answers to customers' most challenging questions.
The company generated revenue of $5.34 billion in fiscal 2020 and
employs 16,400 people worldwide. Information about Agilent is
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version on businesswire.com: https://www.businesswire.com/news/home/20201222005553/en/
Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
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