Affymetrix Receives FDA Clearance of First-of-its-kind Postnatal Test for Developmental Delays and Intellectual Disabilities in

  Affymetrix Receives FDA Clearance of First-of-its-kind Postnatal Test for
  Developmental Delays and Intellectual Disabilities in Children

CytoScan^® Dx Assay represents a technology leap over traditional postnatal
genetic tests and significantly improves diagnostic capability

Business Wire

SANTA CLARA, Calif. -- January 21, 2014

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.

Contact:

Affymetrix, Inc.
Media Contact:
Mindy Lee-Olsen
Vice President, Marketing Services
408-731-5523
mindy_lee-olsen@affymetrix.com
or
Investor Contact:
Doug Farrell
Vice President, Investor Relations
408-731-5285
doug_farrell@affymetrix.com
 
Press spacebar to pause and continue. Press esc to stop.