SBIR-STTR Award

Genital Chiamydia trachomatis infection is currently the most common Sexually Transmitted Disease in the United States. Although it is often relatively asymptomatic and causes serious sequelac, it is readily treatable. Therefore, it is an ideal target for widespread screening. However, current diagnostic methodologies are prohibitively expensive, time consuming and labor intensive. We will demonstrate the basic technical feasibility of developing a calorimetric, presumptive screening test for genital Chlamydia infection in women which is suitable for on-site use by clinical personnel with different training and backgrounds. The test will be rapid, simple, inexpensive, stable at room temperature, compact, and ideal for use in resource poor settings. In Phase II, we will develop, optimize and format its screening test for Chlamydia. In Phase III, we will commercialize the finished product through a license arrangement with one of its corporate marketing partners.Awardee's statement of the potential commercial applications of the research:In addition to their inherent insensitivity, current tests for genital Cb,&my&a infection are complex, time consuming and prohibitively expensive for widespread screening of women at risk. A large worldwide market exists for a rapid, sensitive, simple and cost effective product suitable for on-site presumptive screening. This type of test will be particularly suitable for use in Resource Poor Settings since the test can be performed on-site with results available while the woman is still in the office.National Institute of Allergy and Infectious Diseases (NIAID)

Genital Chlamydia trachomatis (CT) infection is the most common Sexually Transmitted Disease in the United States. Although it is frequently asymptomatic in women and causes serious sequelae, it is readily treatable when diagnosed. Therefore, cervical CT is an ideal target for widespread screening. However, currently available diagnostic methodologies are prohibitively expensive, time consuming, cumbersome and labor intensive. They require refrigeration of selected components, instrumentation, and multiple timed steps and components. As a result, they are not widely utilized for on-site testing. Will demonstrate the technical feasibility of developing a point-of-care, calorimetric, presumptive screening test for cervical Chlamydia infection. The cervical CT test will be the approximate size and shape of a credit card with built-in, specimen activated, positive and negative control elements. To perform the test, a clinician will apply an unprocessed cervical specimen directly from a swab to the test area. No developing solution is required. A vivid color change within five minutes indicates a positive test result. The device will be stable at room temperature. Its ease of use will enable the LCI CT test to be used in a variety of clinical settings in both industrialized and Resource Limited Settings.Awardee's statement of the potential commercial applications of the research:Although tissue culture is the gold standard for the diagnosis of CT infection, it is time consuming and expensive. Commercial test kits for CT are complex, cumbersome, time consuming and expensive for widespread screening of women at risk. A large worldwide market exists for a rapid, accurate, cost effective, simple product suitable for point-of-care presumptive screening of cervical CT. Since the LCI test will produce an easy to interpret color change within five minutes, the woman can be treated before she leaves the clinic or physician's office.National Institute of Allergy and Infectious Diseases (NIAID)