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Jeffrey Modell Foundation, NHGRI and Affymetrix to Develop Newborn Screening Tests

Posted on: Wednesday, 5 October 2005, 09:00 CDT

The Jeffrey Modell Foundation (JMF), the National Human Genome Research Institute (NHGRI) and Affymetrix Inc. (Nasdaq:AFFX) announced today that they will work together to develop two molecular DNA tests that could ultimately help save the lives of children born with severe combined immunodeficiency (SCID) and other primary immunodeficiency (PI) disorders. The JMF, a non-profit organization dedicated to research and education on primary immunodeficiencies, will fund the joint collaboration between these public, private and non-profit organizations.

Primary immunodeficiencies are genetic disorders that lead to an increased susceptibility to infections and currently affect as many as one million Americans and 10 million people worldwide. Experts have identified more than 130 genetic defects that can result in PI. Children born with these defects have immune systems that either lack or have a diminished capacity to fight off infection. However, early diagnosis and treatment can often prevent the recurring infections from causing permanent damage and death.

JMF was established by Vicki and Fred Modell in memory of their son Jeffrey, who died at the age of 15 of PI. "Over the past 20 years, we have sat with too many grieving parents whose infants or very young children were lost because their underlying condition had not been diagnosed in an accurate and timely manner. We have discussed this tragic problem with government agencies, with other non-profits and with industry," said Fred Modell. "We believe it is essential that we 'jumpstart' the development of newborn screening for SCID. That is why we have taken the initiative to make this happen now. This collaboration with Affymetrix and the NHGRI will help give doctors the tools they need to help save these children."

The joint research collaboration aims to demonstrate the feasibility of using a pair of molecular DNA tests to detect PI in newborns and children with recurrent opportunistic infections. The first test, which will be developed by NHGRI, will look for a form of DNA found only in children with normal immune systems. If this first test is abnormal, a secondary test that is based on Affymetrix GeneChip(R) technology will be used to screen for changes in the specific genes associated with PI.

"Primary immunodeficiencies are treatable, but to be treated optimally they must be recognized early in life before severe infections occur," said Jennifer Puck, M.D., Chief of the Genetics and Molecular Biology Branch and Head of the Immunologic Disease Section at NHGRI. "This project will combine a simple 'yes or no' screening test with advanced technology that may help scientists and ultimately physicians identify infants who need urgent medical attention for primary immunodeficiency. The collaboration demonstrates how public, private and non-profit entities can partner to apply the benefits of the human genome sequence to improving health outcomes."

"The Jeffrey Modell Foundation sets the standard in advocating for and promoting advances in newborn screening that could save the lives of children with primary immunodeficiencies," said Janet A. Warrington, Ph.D., vice president, Emerging Markets and Molecular Diagnostics Research and Development at Affymetrix. "We are honored to be working with the JMF and NHGRI on this important project and believe our GeneChip technology can accelerate more comprehensive detection and treatment of primary immunodeficiencies and other genetic conditions."

About the Jeffrey Modell Foundation

The Jeffrey Modell Foundation (JMF) was established in 1986. It is dedicated to basic and clinical research, physician education, patient support, public awareness, and advocacy.

JMF has established 23 Jeffrey Modell Diagnostic and Research Centers throughout the U.S., Canada, Europe, Eastern Europe, the Middle East, and Asia. There are 118 academic medical centers linked in the Global JMF Referral Network. The U.S. Centers for Disease Control and Prevention (CDC) has awarded JMF with a grant for a fourth year to conduct a National Public Service Education and Awareness Campaign. For more information, please visit the Foundation Website at www.info4pi.org.

About the National Human Genome Research Institute

NHGRI is one of the 27 institutes and centers at NIH, an agency of the Department of Health and Human Services. Additional information about NHGRI can be found at its Web site, www.genome.gov. Dr. Puck's work on her SCID screening technique was recently published; see "Development of population-based newborn screening for severe combined immunodeficiency", J Allergy Clin Immunol 2005;115:391-8.

About Affymetrix

Affymetrix scientists invented the world's first microarray in 1989 and began selling the first commercial microarray in 1994. Since then, Affymetrix GeneChip(R) technology has become the industry standard in molecular biology research. 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 1,200 systems have been shipped around the world and more than 3,000 peer-reviewed papers have been published using the technology. Affymetrix' patented photolithographic manufacturing process provides the most information capacity available today on an array, enabling researchers to use a whole-genome approach to analyze the relationship between genetics and health. Headquartered in Santa Clara, Calif., Affymetrix has subsidiaries in Europe and Asia in addition to manufacturing facilities in Sacramento, Calif. and Bedford, Mass. The company has about 900 employees worldwide. For more information about Affymetrix, please visit the company's website at www.Affymetrix.com

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 of the Company's ability to achieve and sustain higher levels of revenue, higher gross margins, reduced operating expenses, uncertainties relating to technological approaches, manufacturing, product development (including uncertainties relating to commercial and technological success of the strategic alliance between The Jeffrey Modell Foundation, the NHGRI and Affymetrix discussed in this press release), personnel retention, uncertainties related to cost and pricing of Affymetrix products, dependence on collaborative partners, uncertainties relating to sole source suppliers, 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, 2004 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.

Source: Business Wire

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