Nanogen Inc has completed internal validation of a DNA-based research protocol for a mutation (S65C) associated with Hereditary Hemochromatosis (HH), a disorder that causes excess iron to be stored in cells of the liver, heart, pancreas and other organs. The protocol is for use in research laboratories on the NanoChip Molecular Biology Workstation. The anticipated users of the protocol include CLIA (Clinical Laboratory Improvement Act) certified laboratories that will have the option to further develop and validate the protocol for internal use in a "home-brew" format.

The Company has now internally validated five DNA-based research protocols for use on the NanoChip Molecular Biology Workstation: Factor II, Factor V, a Factor II and Factor V multiplex format, and MTHFR, all of which are associated with cardiovascular disease, and now HH. These protocols are designed to help researchers identify genetic links in illnesses that may lead to improved treatment and prevention decisions made in patient care.

"The HH protocol is the fifth protocol that Nanogen has internally validated this year. This meets our stated projections for 2001 and demonstrates the significant progress we have made toward expanding the utility of our NanoChip platform," said V. Randy White, Chief Executive Officer of Nanogen. "We expect to convert certain protocols to an ASR model in 2002 once the Company achieves cGMP status for its facilities. It is important to note, however, that we will continue to aggressively develop and internally validate a wide menu of protocols that can be performed on our platform and, due to the flexibility of our platform, we expect partners and customers to continue validating their own test protocols. We believe one of the key factors in the adoption of the NanoChip Workstation will be the expansion of our menu of protocols. As our menu expands, so does the total benefit of the NanoChip platform."

Although HH is one of the most common genetic disorders in the United States, it remains underdiagnosed. Men are about five times as likely to be diagnosed with HH as women due to the loss of iron through menstrual cycles and pregnancy. Men tend to develop symptoms between 40 and 60 years of age while women develop symptoms after menopause. Without proper treatment, the excess iron storage associated with HH can lead to progressive skin pigmentation, cirrhosis, diabetes, arthritis and even death. If detected early, HH is treatable by a process called phlebotomy in which blood is removed. The goal of the treatment is to bring blood iron levels to the low end of the normal range and keep them there.