02-6020. Notice of Availability of Government-Owned Invention; Available for Licensing

AGENCY:

Department of the Navy, DoD.

ACTION:

Notice.

SUMMARY:

The Department of the Navy hereby gives notice of the general availability of exclusive or partially exclusive licenses under the following pending patent. Any license granted shall comply with 35 U.S.C. 209 and 37 CFR part 404. Applications will be evaluated utilizing the following criteria: (1) Ability to manufacture and market the technology; (2) manufacturing and marketing ability; (3) time required to bring technology to market and production rate; (4) royalties; (5) technical capabilities; and (6) small business status.

Patent application Serial Number 10/061036 entitled “Rapid Lateral Flow Assay for Determining Exposure to Mycobacterium Tuberculosis and Other Mycobacteria” filed January 30, 2002. The present invention relates to an assay method and kit for detecting the presence of at least one pre-designated, target antibody to a mycobacterium in a sample selected from one or more patient bodily fluids. The method comprises the following steps: (a) Contacting the sample of one or more patient bodily fluids with at least one mycobacterium antigen on a lateral-flow assay membrane to bind to the target antibody in the sample; (b) previously, simultaneously or subsequently to step a., binding at least one mycobacterium antigen with a conjugated label producing a detectable signal; and (c) detecting the signal whereby the presence of the target antibody is determined in the sample by the intensity or presence of the signal. The method can further comprise the step of evaluating immunization status of the patient from whom the sample came by comparing the signal or lack thereof with immunizations previously received by the patient and in comparison to a known standard control. In a preferred embodiment, the mycobacterium antigen specifically binds to Mycobacterium tuberculosis specific antibodies. Preferably, the immunoassay of the present invention comprises a lateral-flow assay comprising a membrane, a conjugated label pad, and at least one mycobacterium antigen bound to the membrane. In a preferred embodiment, at least one mycobacterium antigen is selected from the group consisting of 38kDa and 16kDa antigens.

DATES:

Applications for an exclusive or partially exclusive license may be submitted at any time from the date of this notice.

ADDRESSES:

Submit applications to the Office of Technology Transfer, Naval Medical Research Center, 503 Robert Grant Ave., Silver Spring, MD 20910-7500, telephone [phone].

FOR FURTHER INFORMATION CONTACT:

Dr. Charles Schlagel, Director, Office of Technology Transfer, Naval Medical Research Center, 503 Robert Grant Ave., Silver Spring, MD 20910-7500, telephone [phone] or e-mail at [e-mail].

Dated: March 6, 2002.

T.J. Welsh,

Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.