COMMERCIAL DEVELOPMENT OF THE BRONX BOX

Confirmation of a diagnosis of tuberculosis requires clear identification of the infecting organism. Historically, this has been accomplished by specific staining (i.e. acid fast staining, and recently by specific fluorescent antibody staining) and liquid culture. More recently, nucleic acid assay techniques have provided improved sensitivity of detection. However they are presently used primarily for identification following culture. The full complement of testing efforts, as done today in official state TB laboratories, requires more than two weeks and more than $1000 to identify and determine antibiotic sensitivity for a patient sample. This level of expertise and armamentarium of technological instrumentation are not available to most of the world's physicians who treat TB. A remarkable achievement by Dr. Bill Jacobs, the modification of a Mycobacterium tuberculosis-specific phage by incorporation of the luciferase gene and promoter, has made it possible to provide the same culture results and antibiotic sensitivity information in 2-3 days at greatly reduce requirement for materials, instrumentation, technician time and skills. This proposal seeks to efficiently transform a laboratory procedure into an inexpensive, easy to perform, reproducible test with great clinical utility. The test will be a disposable, single-use culture manifold of unique design incorporating a dark chamber for film exposure. The design will provide appropriate biohazard safety for technicians and minimize production of biohazard waste. The device will be suitable for use in laboratories without specialized training. The test results will be provided in such a way that the clinician can use the results to rapidly initiate appropriate therapy. PROPOSED COMMERCIAL APPLICATION: 2.1 Billion people harbor a TB infection. UNICEF reports that tuberculosis poses a serious risk to Asia's sustained socioeconomic development. In a recent National Intelligence Estimate, the Central Intelligence Agency singled out drug-resistant TB-and expecially its incidence among immigrants-as a potential threat to national security. Salomon and Murray report that world expenditure on TB therapy and diagnosis was $4.1 Billion (USD) in 1998. Diagnosis of TB worldwide is by sputum smear, with 50% accuracy. This new diagnostic with capabilities of determining antibiotic sensitivity is desperately needed. Short term markets will be as an adjunct diagnostic in the developed world.