CEDIA(R) HOMOGENEOUS IMMUNOASSAYS - CURRENT STATUS AND FUTURE-PROSPECTS

The CEDIA(R) technology utilizes genetically-engineered enzyme fragmen ts to perform homogeneous immunoassays. CEDIA products allow rapid, co nvenient and highly sensitive measurement of therapeutic and abused dr ugs, vitamins and hormones. Current efforts are directed toward expans ion of the assay menu; new fully-automated, no-boil assays for vitamin B-12 and folate, an improved three-reagent digoxin assay and new test s for anti-arrythmic and anti-microbial drugs and drugs of abuse are u nder development. In addition, a new assay methodology for homogeneous measurement of very low-concentration proteins has been developed. Th is approach uses conjugates of recombinant enzyme fragments with antib odies, and reagents are present in excess to overcome low analyte conc entrations. A prototype fully-automated, homogeneous hCG assay has bee n developed with sensitivity (least detectable dose) of 10 mIU/mL. Fut ure improvements may include genetic engineering of antibodies for imp roved affinity and specificity, and recombinant antibody-enzyme fragme nt chimeras.