The P1 has invented a means of compacting cytochemical information from two activities, such as intracellular enzyme actions, into one signal. This method enables, for example, cell identification by one characteristic and a cell quality, such as degree of maturation, by another. Output becomes readable by less complex instrumentation. Cytochemistry of the AND Gate will be applied to several existing clinical cytometers which have limited parameter expansion capability for hardware reasons. The same instruments will then have new clinical and diagnostic information. A bead model used to develop the chemistries will be further developed into an improved equivalent of ELISA assays where wash of a solid phase is not required. Phase I will demonstrate feasibility of the chemistries. Phase II will adapt the chemistries to specific instruments in the field that are manufactured by other companies. Diagnostic application will be found for the products in hematological screening by automated instrumentation, in monitoring diseases such as infection, marrow dysplasia and leukemia, an In screening for chromosomal disorders of a fetus in pregnancy. Product definition of the bead assay should be complete by the end of Phase I. PROPOSED COMMERCIAL APPLICATIONS: Envisioned products resulting from this research are new tests for existing devices. Actual products are new software and new reagents. Product sales in the introduction year would be $10MM and grow to $50MM in 5 years. Part of the benefit to the collaborating manufacturers will be extension of product life in a competitive market, at least equivalent to the new reagent sales. A decrease in amniocentesis means a potential savings of $1.61313 to the US health care system.
Thesaurus Terms: enzyme activity, enzyme linked immunosorbent assay, hematology, histochemistry /cytochemistry, technology /technique development biomedical automation, biomedical equipment development, cell type, computer program /software
