Catch Incorporated intends to develop and commercialize a fully automated, high throughput, inexpensive, homogeneous enzymatic assay for the measurement of homocysteine using common clinical analyzers. High plasma concentrations of homocysteine are correlated with increased risks for coronary heart disese, stroke, atherosclerosis and other diseases. Increased levels of homocysteine in the blood are associated with an increased risk for the development of AIzheimer's disease and other dementias. Accurate assessment of homocysteine concentrations in the general population has been hindered by the high expense and specialized equipment characteristic of the presently available homocysteine methods. Catch Incorporated has developed an inexpensive homogeneous technology for homocysteine measurement. High throughput testing on commonly available laboratory analyzers is now possible. The assay involves first the reduction of disulfide bonds followed by the interconversion of homocysteine and cytathionine catalyzed by the enzymes cystathionine beta-synthase and cystathionine beta-lyase. The rate of pyruvate produced by the cycling reaction is proportional to homocysteine levels in plasma. This phase of our studies will include the development of FDA cleared instrument applications for many of the most commonly used clinical analyzers. Work involving reagent simplication by combining the reducing agent with reagent one will be completed show that applications for still more instruments can be designed. Production of reagents and calibrators will be scaled-up along with quality control processes in anticipation of commercialization.
