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 Applications

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI048973-01
Application #
6293543
Study Section
Special Emphasis Panel (ZRG1-SSS-K (01))
Program Officer
Sizemore, Christine F
Project Start
2001-04-01
Project End
2002-03-31
Budget Start
2001-04-01
Budget End
2002-03-31
Support Year
1
Fiscal Year
2001
Total Cost
$294,875
Indirect Cost
Name
Sequella, Inc.
Department
Type
DUNS #
125129606
City
Rockville
State
MD
Country
United States
Zip Code
20850
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