Affymetrix Technology Powers Cincinnati Children’s Hospital’s Innovative Test for Jaundice
December 09 2008 - 8:00AM
Business Wire
Affymetrix, Inc. (Nasdaq:AFFX) today announced that its technology
was used by the Cincinnati Children�s Hospital Medical Center to
develop an innovative molecular diagnostic test designed to help
diagnose the genetic defects in patients with inheritable forms of
jaundice. Jaundice is the most common symptom of liver disease in
young children. Cincinnati Children�s has made the CLIA- and
CAP-approved laboratory developed test available to clinicians
around the world. Research shows jaundice occurs in one out of
every 2,200 live births in the U.S.1 Although many cases resolve
spontaneously, patients with pathologic jaundice (also known as
cholestasis) may progress to end-stage liver disease or cirrhosis.
Until now, evaluation has frequently determined the extent of liver
injury in patients with jaundice. Cincinnati Children�s intends the
Jaundice Chip to enable diagnoses to be expanded to include genetic
causes and more precisely identify patients at high risk for
progressive liver disease. A team of scientists led by Jorge
Bezerra, M.D., professor of pediatrics and director of
gastroenterology research at Cincinnati Children�s, designed the
Jaundice Chip, a custom microarray. In a study published in the
January 2007 issue of the Journal of Gastroenterology, Dr Bezerra
reported the Jaundice Chip is highly effective in detecting the
five most common genetic mutations in children with inherited
causes of jaundice. Those five diseases represent about half of all
pediatric chronic liver disease cases.2 �We are proud of the team
at Cincinnati Children�s for creating a custom array that enables
researchers to draw clearer conclusions as to the causes of
jaundice,� said Kevin King, president of Affymetrix. �This test is
further proof of Affymetrix enabling scientists to innovate and use
our products to meet the unmet needs of the market.� Affymetrix
offers a continuous path to discover, develop, and commercialize
complex biomarker signature assays. The GeneChip� System 3000Dx is
the only microarray instrumentation platform to receive regulatory
clearance by the U.S. FDA and to be CE marked in the European Union
for in vitro diagnostic use. The CLIA-certified Affymetrix Clinical
Services Laboratory (ACSL) offers microarray-based molecular
diagnostic patient and clinical trial testing services which enable
customers to leverage Affymetrix' technology and experience to
bring more effective molecular diagnostic tests to patients faster
than ever before. 1 Arya G. et al., Pediatric liver disease in the
United States: epidemiology and impact, J. Gastroenterol. Hepatol,
17(5): 521-5, (May 2002) 2 Liu C. et al., Novel resequencing chip
customized to diagnose mutations in patients with inherited
syndromes of intrahepatic cholestasis, J. Gastroenterol. Hepatol,
132(1):119-26. (Jan 2007) For more information on the Jaundice Chip
developed on the Affymetrix platform, visit Cincinnati Children�s
at:
http://www.cincinnatichildrens.org/health/subscribe/ped-insights/05-07/jaundice-chip.htm
About Affymetrix Affymetrix GeneChip� microarray technology is the
industry-standard tool for analyzing complex genetic information.
After inventing microarray technology in the late 1980s, Affymetrix
scientists have been dedicated to developing innovative products
that provide researchers with a more complete view of the genome.
These products continue to accelerate genetic research and enable
scientists to develop diagnostics and tailor treatments for
individual patients by identifying and measuring the genetic
information associated with complex diseases. Today, Affymetrix
technology is used by the world�s top pharmaceutical, diagnostic
and biotechnology companies, as well as leading academic,
government and not-for-profit research institutes. More than 1,800
systems have been shipped around the world and more than 14,000
peer-reviewed papers have been published using the technology.
Affymetrix is headquartered in Santa Clara, Calif., and has
manufacturing facilities in Sacramento, Calif., Cleveland, Ohio,
and Singapore. The company has about 1,100 employees worldwide and
maintains sales and distribution operations across Europe and Asia.
For more information about Affymetrix, please visit the company�s
website at www.affymetrix.com. 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, including,
but not limited to: risks and uncertainties relating to commercial
success of the agreement with Cincinnati Children�s discussed in
this press release; risks of the company�s ability to achieve and
sustain higher levels of revenue, higher gross margins and reduced
operating expenses; uncertainties related to technological
approaches, manufacturing and product development; personnel
retention; uncertainties related to cost and pricing of Affymetrix
products; dependence on collaborative partners; uncertainties
related to sole-source suppliers; risks associated with past and
future acquisitions; uncertainties relating to FDA and other
regulatory approvals; competition; risks relating to intellectual
property of others and the uncertainties of patent protection and
litigation. These and other risk factors are discussed in
Affymetrix� Form 10-K for the year ended December 31, 2007, and
other SEC reports, including its Quarterly Reports on Form 10-Q for
subsequent quarterly periods. Affymetrix expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Affymetrix� expectations with regard thereto
or any change in events, conditions or circumstances on which any
such statements are based. NOTE: Affymetrix, the Affymetrix logo
and GeneChip� are registered trademarks owned or used by Affymetrix
Inc.
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