The goal of this project is to successfully develop and commercialize a simple, rapid, point of care test for the combined detection of chlamydia and gonorrhea from a single endocervical or male urethral swab sample. With this combined test, a physician will be capable of diagnosing chlamydia, gonorrhea, or co-infections and providing appropriate treatment at the time of a patient s first visit to the clinic. This will eliminate the need for subsequent patient contact to inform the test results and/or prescribe appropriate therapy. In Phase I on this project, BioStar, in collaboration with Dr. Edward Hook at the University of Alabama School of Medicine and Dr. Ellena Peterson at the University of California, Irvine, will conclude feasibility on the development of an assay for the detection of Neisseria gonorrhea. Feasibility will also be demonstrated for combining BioStar's current chlamydia assay with the assay for gonorrhea. The combined test will be developed using BioStar s patented Optical Immuno-Assay technology (OIA). Phase II of this project will focus on final optimization of the combined test and will bring the test through full development including assay transfer to manufacturing, scale-up of production, and conducting clinical trials for assay validation and FDA 510K submission.
