Assay Detects Genetic Anomalies and Helps Move Inquiries from Cause
to Care Faster
SANTA CLARA, Calif.(BUSINESS WIRE)
Agilent Technologies Inc. (NYSE: A) has announced that it has obtained
510(k) clearance from the U.S. Food and Drug Administration (FDA) for
the GenetiSure Dx Postnatal Assay: its first comparative genomic
hybridization (CGH) assay for diagnostic use. This assay enables
clinical geneticists to detect genetic aberrations associated with
developmental delay, intellectual disabilities, congenital
irregularities, and unexplained dysmorphic features, earlier and more
accurately than traditional methods.
The GenetiSure Dx Postnatal Assay is the result of an extensive clinical
validation utilizing 900 samples from multiple partner laboratories and
brings CGH technology into diagnostics. Based on Agilent's proprietary
array for comparative genomic hybridization, this assay provides data on
copy number variations and absence of heterozygosity in genomic DNA
obtained from peripheral whole blood in patients who have been referred
for chromosomal testing based on clinical presentation. The ability to
detect both types of aberrations using a single assay provides greater
diagnostic yield and faster time-to-results.
Previously available only in Europe, U.S. clinical genetic scientists
can now use this assay to help identify a definitive genetic diagnosis,
and rapidly change the focus of a medical investigation from finding the
cause to administering appropriate medical care and family support.
"Obtaining FDA clearance of the GenetiSure Dx Postnatal Assay is a major
milestone for us and solidifies Agilent's commitment to bringing
complete diagnostic solutions into routine clinical laboratories," said
Kamni Vijay, vice president and general manager of Agilent's Genomics
Solutions Division and Clinical Applications Division. "By providing a
validated workflow that extends from DNA to data analysis, this assay
allows traditional karyotyping labs to easily adopt array-based
cytogenetic testing without the high cost of extensive validation.
This assay is intended for use on the Agilent SureScan Dx Microarray
Scanner System, a Class II Exempt Medical Device, and analyzed with
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences,
diagnostics and applied chemical markets. With more than 50 years of
insight and innovation, Agilent instruments, software, services,
solutions, and people provide trusted answers to its customers' most
challenging questions. The company generated revenues of $4.20 billion
in fiscal 2016 and employs about 13,000 people worldwide. Information
about Agilent is available at www.agilent.com.
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Naomi Goumillout, +1 978-314-1862
Source: Agilent Technologies Inc.