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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, Public Health Service, HHS.

# ACTION:

Notice. 

# 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                               ( print 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:                     *carsonsu@mail.nih.gov.*

### 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