The fight against cancer, heart disease, HIV, and all diseases are slow. Lives are being lost. The public spends over $1 trillion a year on health care. The government spends that much again. The tool used most in the fight against cancer employs fluorescent dyes to indicate the presence of cancer, to discover new ways to test for cancer, and to discover medicinal cures. Millions of tests are performed each year using thousands of tiny spots on a microscope slide, called a microarray. These spots fluoresce when a sought-after biological indication is present. The problem is that this ubiquitous method of research and diagnosis can detect less than half of the biological information needed to end cancer because the fluorescent light signal is very weak. The proposed project will increase the sensitivity of fluorescence assays 1000-fold. This innovation will revolutionize the battle against cancer and all diseases. The mission of NCI is to discover and develop new technology for the fight against cancer. This project will continue the development of metal enhanced fluorescence (MEF) begun under a previous Phase I SBIR grant from NCI. MEF uses thin-film technology to deposit layers of metal particles and dielectrics on microarray substrates. MEF has been repeatedly proven to increase the fluorescence assay sensitivity 40 to 100 fold. This project will transfer MEF technology to a manufacturing environment, optimize the manufacturing protocols, and pilot test the first products. Cancer DNA assays will be performed at the NCI Microarray Center to evaluate and validate the performance of the new product. In addition, this project will integrate two commercially available assay technologies with the MEF microarray. The active surface of a microarray substrate must be able to bind biological material efficiently. GenTel BioSurfaces, Inc., provides surface chemistry which is proven to increase binding by a factor of 7-10 compared to all other available substrates. Their surface chemistry combines with MEF to produce an assay sensitivity increase in the range of 100 to 1000. Martek sells super bright fluors that are proven to increase the fluorescence signal 20 to 300-fold compared to conventional fluors. Microcosm has proven that MEF increases the light output of Martek fluors another 40-fold. The integration of Martek labeled assay reagents, Gentel's surface chemistry, and Microcosm MEF substrates promises a multiplicative increase in assay sensitivity exceeding 1000-fold. Martek and Gentel products are on the market. Based on over three years of development at Microcosm, this integrated MEF substrate is ready for commercialization. With this project, a universally needed and revolutionary new microarray assay product line can enter the market in less than two years. ? ? ?
