Bacterial vaginosis (BV) is now recognized as a risk factor for adverse reproductive health sequelae in women. It results from a complex disturbance of the vaginal ecology. Normal vaginal flora (FLORA) is usually characterized by a predominance of aerobic lactobacilli. BV results from the replacement of the normal FLORA with a mixed FLORA consisting primarily of facultative and anaerobic organisms. Vaginal lactobacilli act as endogenous vaginal microbicides by producing H2O2 and other factors that can inhibit growth or survival of genital pathogens. The use of a vaginal suppository containing viable lactobacilli is now being evaluated as a prophylaxis against genital tract infection. Unfortunately, the recommended methods for detecting FLORA changes associated with BV [the Amsel criteria (AMSEL) and Gram stain (GRAM)] are unsuitable for direct use by patients and consumers. Litmus Concepts, Inc. (LCI) has shown that its resident technology can be modified to distinguish women with a predominance of normal FLORA from women with a disturbed FLORA. This technology advance will be incorporated into a consumer device to permit women to determine their own vaginal flora status. After completing product development, LCI will manufacture three commercial lots of the product; test the ability of untrained women to self-sample VF, use the product, and interpret test results. Clinical data will be compiled into a regulatory submission to the FDA to obtain clearance to market the device. PROPOSED COMMERCIAL APPLICATION: The LCI product will be suitable for direct use by women as a surrogate for the presence of normal FLORA. By providing an objective, reproducible, visual determination quickly and easily, the LCI product can assist women to monitor their gynecological health. A consumer use product can reduce health care costs, improve quality of life and assist physicians in monitoring patients.
