SANTA CLARA, Calif.–Affymetrix, Inc. (Nasdaq:AFFX – News) 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)