Covalent Technology Corporation has a proprietary Visual Immunoassay (VIA) technology that is sensitive, rapid, easy to perform, and cost effective. It is widely acknowledged that a simple, rapid test for ovulation in women is needed. There is currently an unmet need for a test to detect estrogen secretion by the ovarian follicle just prior to ovulation. A suitable test for E1-3-G should be a successful commercial product and would be used by physicians in the monitoring of infertility patients, especially in association with in vitro fertilization programs. If the assay was available at a low cost, it would also be used in homes to predict time of ovulation and be a major advance for use with natural family planning methods. Although an hLH test might have less success commercially because competing products are already in the market place, the economic feasibility, user friendliness, specificity and sensitivity, reagent stability, and speed of the VIA test should give it high commerical potential, especially in view of its easy applicability to an over-the-counter home test situation. In Phase II, CTC will further optimize these simple VIA tests for the measurement of hLH and E1-3-G in urine, perform stability studies, develop and refine kit design, incorporate more user-friendly devices, and perform field testing. The long term objectives are the development of a marketable kit and obtain FDA approval for Phase III.
