[Federal Register Volume 71, Number 147 (Tuesday, August 1, 2006)]
[Notices]
[Pages 43501-43502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12338]


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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.

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

    Description of Technology: Age-related macular degeneration (AMD) 
is a 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

[[Page 43502]]

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 Application No. 60/772,989 filed 13 
Feb 2006 (HHS Reference No. E-042-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Susan Carson, D.Phil.; 301/435-5020; 
[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 24, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-12338 Filed 7-31-06; 8:45 am]
BILLING CODE 4140-01-P