ZYMERON CORPORATION — Department of Health and Human Services SBIR Phase I: 86

Description

Histoplasmosis is the most common endemic fungal infection in North America and in certain areas of Mexico and Central and South America. In the United States, of the endemic mycoses, histoplasmosis was the most common cause for hospitalization and death. Histoplasmosis can cause a wide spectrum of manifestations that range from subclinical infections to more severe progressive disseminated disease, particularly for immunosuppressed individuals. Currently, diagnosis of histoplasmosis relies on demonstration of the fungus in clinical specimens by histopathology or culture, which can take weeks to provide a result. This makes early diagnosis impossible and has resulted in a common and widespread practice of starting antifungals prophylactically or empirically, in the absence of any confirmation of fungal infection or disease. Although this approach is considered “standard of care” by many treating physicians, this also results in unnecessary antifungal drug treatment, adverse drug reactions, and increased healthcare expenditure. Therefore, early diagnosis is critical for successful and efficient treatment of histoplasmosis. Zymeron’s POC Histoplasmosis diagnostic test provides a rapid, noninvasive, and highly sensitive method allowing physicians to make rapid diagnosis in the absence of culture or pathological confirmation and also offers an option for monitoring treatment response.