[Federal Register Volume 67, Number 49 (Wednesday, March 13, 2002)]
[Notices]
[Pages 11294-11295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6020]


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DEPARTMENT OF DEFENSE

Department of the Navy


Notice of Availability of Government-Owned Invention; Available 
for Licensing

AGENCY: Department of the Navy, DoD.

ACTION: Notice.

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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 (301) 319-7428.

FOR FURTHER INFORMATION CONTACT: Dr. Charles Schlagel, Director, Office 
of

[[Page 11295]]

Technology Transfer, Naval Medical Research Center, 503 Robert Grant 
Ave., Silver Spring, MD 20910-7500, telephone (301) 319-7428 or e-mail 
at [email protected].

    Dated: March 6, 2002.
T.J. Welsh,
Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy, 
Federal Register Liaison Officer.
[FR Doc. 02-6020 Filed 3-12-02; 8:45 am]
BILLING CODE 3810-FF-P