March 30, 2024
Report

Antibody-Based Diagnostics: Fast Track Production

Abstract

The major product line for NHD is the development, marketing and sale of rapid antibody based diagnostic kits. Studies conducted by the World Health Organization in 1996 showed that infectious and parasitic diseases accounted for 43% of the 40 million deaths in developing countries. In the United States alone, for example, the death rate due to infectious diseases rose 58% from 1980 to 1992. The incidence of food-borne illness continues to rise. As many as 81 million illnesses and 9,000 deaths occur each year in the United States from food-borne microorganisms. In addition, pesticides in food give rise to an estimated 6,000 cancer cases annually in the U.S. The Environmental Protection Agency (EPA) estimated, in the early 1990s, that approximately 43% of the water systems serving 120 million people had EPA violations, and nearly one million people became ill due to contaminated water. In fact, "Boil Water" alerts have been issued for cities such as Milwaukee, New York City, Washington D.C., and others. With the basic infrastructure in the U.S. water systems being quite old, there remains a risk of system failure and contamination. The largest market driver for the diagnostics business is cost—routine analyses for DOD, EPA, USDA, FDA, WHO and veterinary applications run between $3-$7/test. Special high demand tests (usually patent protected and unique, can run $15-$25/test). The proposed suite of diagnostics test kits developed under this project is expected to result in penetrating several high volume markets; these include WHO, DOD, CDC, environmental, and food safety sectors.

Published: March 30, 2024

Citation

Loomis L., and J.E. Morris. 2011. Antibody-Based Diagnostics: Fast Track Production Richland, WA: Pacific Northwest National Laboratory.