Affymetrix Receives FDA Clearance of First-of-its-kind Postnatal Test for Developmental Delays & Intellectual Disabilities in...
January 21 2014 - 6:00AM
Business Wire
CytoScan® Dx Assay represents a technology leap over traditional
postnatal genetic tests and significantly improves diagnostic
capability
Affymetrix, Inc. (NASDAQ: AFFX) today announced that it has
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to market its CytoScan® Dx Assay. This assay
is intended for the postnatal detection of DNA copy number variants
(CNV) in patients referred for chromosomal testing. CytoScan Dx
Assay is designed to help physicians diagnose children’s
developmental and intellectual disabilities more comprehensively by
enabling a high-resolution genome-wide analysis of genetic
aberrations. High resolution analysis can reveal small aberrations
not readily seen using traditional techniques.
“This clearance is first-of-its-kind, and represents a leap
forward in molecular genetic testing. CytoScan Dx Assay is the
first FDA-cleared test that analyzes the whole genome in a single
assay at unprecedented resolution, which significantly improves
diagnostic capability. Developing and clearing this assay establish
Affymetrix as a leader in advancing molecular diagnostics by
bringing high quality genomic tools into routine application in the
clinic,” said Frank Witney, CEO and President of Affymetrix. “We
expect to be making CytoScan Dx Assay available to laboratories
within the US in the next few months. In addition, the clearance by
the FDA is an important milestone for supporting adoption in other
key countries around the world where they are now evaluating
advanced tools and tests like this.”
"We are pleased to have been selected by Affymetrix to be part
of the clinical trial for CytoScan Dx Assay and found the
performance data of this assay very impressive. With two to three
percent of children in the United States having some form of
developmental delay or intellectual disabilities, finding a
diagnosis for the patient and their family can become a lengthy
odyssey. This assay represents the best option for accelerating an
accurate diagnosis," said Alka Chaubey, PhD, Director of the
Greenwood Genetic Center's Cytogenetics Laboratory.
For additional information on CytoScan Dx Assay, please email us
at marketing@affymetrix.com
PLEASE NOTE: Affymetrix, the Affymetrix logo, and
CytoScan are the property of Affymetrix, Inc. All other trademarks
are the property of their respective owners.
Forward-looking statements
All statements in this press release that are not historical are
"forward-looking statements" within the meaning of Section 21E of
the Securities Exchange Act as amended, including statements
regarding Affymetrix' "expectations," "beliefs," "hopes,"
"intentions," "strategies," or the like. Such statements are
subject to risks and uncertainties that could cause actual results
to differ materially for Affymetrix from those projected. These and
other risk factors are discussed in Affymetrix' Form 10-K for the
year ended December 31, 2012, and other SEC reports for subsequent
quarterly periods.
About Affymetrix
Affymetrix technologies enable multiplex and simultaneous
analysis of biological systems at the cell, protein, and gene
level, facilitating the rapid translation of bench-top research
into clinical and routine use for human health and wellness.
The Company provides leadership and support, partnering with
customers in pharmaceutical, diagnostic, and biotechnology
companies, as well as leading academic, government, and non-profit
research institutes in their quest to use biology for a better
world.
More than 2,300 microarray systems have been shipped around the
world and more than 48,000 peer-reviewed papers have been published
citing Affymetrix technologies. Affymetrix is headquartered in
Santa Clara, California, and has manufacturing facilities in
Cleveland, Ohio, San Diego, Vienna, and Singapore. The Company has
about 1,100 employees worldwide and maintains sales and
distribution operations across Europe, Asia, and Latin America. For
more information about Affymetrix, please visit
www.affymetrix.com.
Affymetrix, Inc.Media Contact:Mindy Lee-OlsenVice
President, Marketing
Services408-731-5523mindy_lee-olsen@affymetrix.comorInvestor
Contact:Doug FarrellVice President, Investor
Relations408-731-5285doug_farrell@affymetrix.com
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