[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Pages 46490-46491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6879]


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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 expeditions 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

[[Page 46491]]

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, MD 20852-3804; 
telephone: 301/496-0220. A signed Confidential Disclosure Agreement 
will be required to receive copies of the patent applications.

Complement Regulatory Gene Variants as Predictive Tests for Age-related 
Macular Degeneration (AMD)

Description of Technology

    Age-related macular degeneration (AMD) is complex multigenic 
disorder that affects the central region of the retina (macula) and is 
the leading cause of legal blindness in developed countries. Age, 
lifestyle (e.g., smoking, diet) and genetic predisposition are major 
risk factors for AMD and 1.75 million adults over 40 are affected by 
advanced AMD in the United States with a further 7 million considered 
to be at risk (defined by the presence of large retinal deposits or 
drusen, which are the hallmark of this disease). A variety of immune-
associated molecules including immunoglobulins, complement components, 
activators and regulators, etc. are associated with drusen and evidence 
suggests that AMD, like other age-related diseases such as Alzheimer's 
disease and atherosclerosis, involves a major inflammatory component. 
Several disease-susceptibility genes have been identified in family 
studies of macular degeneration and in patient cohorts by several 
groups including NIH researchers and their collaborators, and variants 
in the factor H gene (CFH)), a major inhibitor of the alternative 
complement pathway, have been associated with the risk for developing 
AMD.
    NIH researchers and their collaborators have now extended this work 
to two other regulatory genes of this pathway, Factor B (BF) and 
complement component 2 (C2). These genes were screened for genetic 
variation in two independent cohorts comprised of ~900 AMD cases and 
~400 matched controls. Haplotype analyses revealed a significant common 
risk haplotype (H1) and two protective haplotypes (H7 and H10). 
Combined analysis of the C2/BF haplotypes and CFH variants shows that 
variation in the two loci can predict the clinical outcome in 74% of 
the cases and 56% of the controls (Nature Genetics (2006) 38, 458). 
This suggests that these variants can be used as predictive genetic 
tests in combination with other potential risk factors.
    Available for licensing are methods for identifying a subject at 
increased risk for developing AMD by determining the presence of 
protective genotypes at either the BF/C2 locus and at the CFH locus. 
Microarrays and kits are also provided. The complex and polygenic 
nature of AMD suggests that the protective and risk haplotypes claimed 
here can be of great value not only to companies targeting Macular 
Degeneration but perhaps more broadly to those involved in complement-
mediated inflammatory disorders.

Inventors

    Michael Dean (NCI), Bert Gold (NCI) et al.

Patent Status

    U.S. Provisional Patent Application No. 60/772,989, filed 13 
February 2006 (HHS Reference No. E-042-2006/0-US-01).

Licensing Status

    Available for non-exclusive or exclusive licensing.

Licensing Contract

    Susan Carson, D.Phil.; 301-435-5020; mail to: 
[email protected].

Collaborative Research Opportunity

    The NCI Laboratory of Genomic Diversity is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize functional or 
genetic tests on complement genes and proteins. Please contact Kathleen 
Higinbotham at 301-846-5465 for more information.

    Dated: July 28, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 06-6879 Filed 8-11-06; 8:45 am]
BILLING CODE 4140-01-M