Genesis Labs has exclusive patent rights to a novel enzyme- immunoassay dipstick. This method has been reduced to practice for serum theophylline in the required therapeutic range of 2-40 micrograms per ml. An exciting aspect of this effort is our ability to provide the physician with a simplified assay system which does not require customary pipetting, washing and separation steps. The result is available within two minutes, allowing the treating physician to make rapid adjustments in drug regimens while the patient is still in the doctor's consulting room. Since all of our Phase I aims have been achieved, we intend to build on this progress in Phase II in the following way: 1) Investigate different formats of the assay; 2) Scale up reagent production; 3) Examine alternative signal generating systems; 4) Modify our current instrumentation making it suitable for patient evaluation within a doctor's office setting; 5) Conduct pilot scale manufacturing; and 6) Initiate preliminary clinical studies for FDA approval purposes. Assays of this type will have considerable and favorable impact on health care cost containment policies without lessening the quality of care provided currently by health service personnel.
