[Federal Register Volume 73, Number 144 (Friday, July 25, 2008)]
[Notices]
[Pages 43454-43455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17021]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

T-Cell Enumeration Using Dried Blood Spots as a Surrogate for CD4+ T-
Cell Counts To Monitor HIV+ Patients

    Description of Technology: Available for licensing and commercial 
development is a novel method for enumerating T-cells in HIV+ patients 
using dried blood spots, avoiding the need for fresh blood samples. The 
method relies on the distinctive nature of the TCR-[beta] gene, which 
undergoes a rearrangement during T-cell development that is required to 
produce a functional T-cell receptor protein. Since only mature T-cells 
contain a rearranged TCR-[beta] gene, the method quantifies the number 
of T-cells in a patient sample by quantifying the number of cells that 
contain a rearranged TCR-[beta] gene. In addition to dried blood spots, 
the assay can be also used with a wide variety of sample types from 
which T-cell counts were previously impossible to obtain, such as swabs 
and tissue slides. In addition, this method can be used for monitoring 
of a variety of T-cell leukemias/lymphomas, and easily adapted to 
monitor B-cell levels found in B-cell leukemias/lymphomas.
    The assay was found to accurately predict TCR-[beta] levels 
(r=0.985, p<0.0001), and to correlate well with known CD4 counts 
(r=0.670, p<0.0001). Therefore, this novel method can be used to 
monitor HIV infection in order to determine antiretroviral therapy 
(ART) initiation and monitoring. A large international effort has been 
made to provide ART to the more then 33 million HIV+ people worldwide, 
but significant hurdles remain to large-scale implementation due to the 
lack of medical and laboratory infrastructure found in the developing 
world, where the majority of HIV+ individuals are found. In particular, 
a CD4 count, which requires fresh whole blood, a reliable cold-
transport chain, and an expensive FACS based reader, is required to 
monitor patients and determine ART initiation. This requirement has 
become one of the largest impediments to expanding ART around the 
world. Therefore, this novel method provides a superior functional 
assay for HIV disease staging that does not require cold storage or 
fresh sample processing. Dried blood spots are an ideal sample 
collection method for large scale monitoring in the developing world 
due to the relatively simple manner in which samples can be obtained 
and the high stability of the sample in the absence of refrigeration. 
This method provides an easier and less expensive method for HIV 
monitoring for the developing world, and could be also used as an at 
home monitoring system for HIV-infected patients in developed 
countries.
    Development Status: Fully developed and testing in HIV+ subjects 
has been performed with successful results.
    Inventors: Andrew D. Redd and Thomas C. Quinn (NIAID).
    Relevant Publication: A manuscript describing the above technology 
will be available as soon as it is accepted for publication.
    Patent Status: U.S. Provisional Patent Application No. 61/131,954, 
filed 12 June 2008, entitled ``Monitoring TCR-[beta] to Determine HIV 
Therapy and Disease Progression'' (HHS Reference No. E-203-2008/0-US-
01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, PhD, MBA; 301-435-
4507; [email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases, Laboratory of Immunoregulation, 
International HIV and STD Unit, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize TCR-[beta] enumeration to monitor 
HIV+ patients, as well as other diseases or syndromes in which T-cell 
monitoring is commonly performed. Please contact Andrew Redd, PhD, at 
410-614-0813 or [email protected] for more information.

Metabolic Biomarkers Indicate Exposure to Gamma Radiation

    Description of Technology: Available for licensing and commercial 
development are methods of diagnosing exposure to gamma radiation in a 
mammal. Gamma radiation has both short-term and long-term adverse 
health effects including cancer. Urine samples collected from exposed 
mouse models irradiated at 0, 3, and 8 Gy (2.57 Gy/min) were analyzed 
by ultra-performance liquid chromatography-time of flight mass 
spectrometry (UPLC-TOFMS). Statistical analysis revealed that the 
following metabolomic markers were associated with exposure: 2'-
deoxyxanthosine, xanthosine, 2'-deoxyuridine, 2'-deoxycytidine, N-
hexanoylglycine and P-thymidine are urinary biomarkers of 3 and 8 Gy 
exposure. 3-hydroxy-2-methylbenzoic acid 3-O-sulfate and xanthine are 
elevated in urine of mice exposed to 3 but not 8 Gy, and taurine is 
elevated after 8 but not 3 Gy exposure.
    Applications: Radiation Exposure; Metabolomics.
    Inventors: Frank J. Gonzalez (NCI), John Tyburski (NCI), Kristopher 
Krausz (NCI), Andrew Patterson (NIGMS), et al. Publications:
    1. Patterson AD, Li H, Eichler GS, Krausz KW, Weinstein JN, Fornace 
AJ, Gonzalez FJ, Idle JR. UPLC-ESI-TOFMS-based metabolomics and gene 
expression dynamics inspector self-organizing metabolomic maps as tools 
for understanding the cellular response to ionizing radiation. Anal 
Chem. 2008 Feb 1;80(3):665-674.
    2. Tyburski JB, Patterson AJ, Krausz KW, Slavk J, Fornace AJ, 
Gonzalez FJ, Idle JR. Radiation metabolomics: Identification of 
minimally invasive urine biomarkers for gamma radiation exposure in 
mice. Radiat Res. 2008 Jul;170(1):1-14.
    Patent Status: U.S. Patent Application No. 12/121,208 filed 15 May 
2008 (HHS Reference No. E-070-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Metabolism, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the development of

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biomarkers for radiation gamma exposure and cell damage. Please contact 
John D. Hewes, PhD, at 301-435-3121 or [email protected] for more 
information.

    Dated: July 17, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-17021 Filed 7-24-08; 8:45 am]
BILLING CODE 4140-01-P