Over the past decade tuberculosis has re-emerged as a global epidemic. The causative agent is the bacterium Mycobacterium tuberculosis (Mtb) which is now prevalent as multi-drug-resistant variants. The disease kills 3 million people per year. Mtb is also a major opportunistic infection in AIDS patients where there are suggestions the HIV virus may activate latent TB. The available diagnostic tests for Mtb are expensive and make use of crude extract produced from the organism, or utilize certain recombinant antigens of poor specificity. These tests aimed at detecting Mtb specific antibodies do not offer specificity nor the sensitivity needed for precise serodiagnosis of TB, particularly in smear negative patients. The studies proposed in this grant will lead to inexpensive, reliable and standardized tests with a large market potential. They will exploit the expertise of InBios to develop rapid tests in combination with Corixa's novel TB antigens derived through serological expression cloning and their extensive serum bank. The studies will also benefit from a close collaboration with renowned consultants domestically and in developing countries, and access to their serum banks.
The proposed studies will lead to the commercialization of a diagnostic test that will aid in the diagnosis of Mycobacterium tuberculosis in the USA and worldwide. The estimated worldwide market for such a test is in excess of $100 million dollars, based on a cost of $1.00 per test.
