Automated Eye Disease Screening System

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44EY020015-02A1
Agency Tracking Number: R44EY020015
Amount: $1,201,866.00
Phase: Phase II
Program: SBIR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NEI
Solicitation Number: PA11-096
Small Business Information
2501 Yale Blvd. SE, ALBUQUERQUE, NM, -
DUNS: 804567217
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: Y
Principal Investigator
 (505) 508-1994
Business Contact
Phone: (505) 508-1994
Research Institution
DESCRIPTION (provided by applicant): This proposed project is motivated by the fact that comprehensive, broad-scale screening for eye diseases such as age-related macular degeneration (AMD), glaucoma, and diabetic retinopathy (DR), including advanced stages, is economically prohibitive without the introduction of computer-assisted diagnosis of retinal images. According to the CDC approximately 80 million people in the U.S. have some form of eye disease, including 20 million diabetics at risk for retinopathy, 60 million at risk for glaucoma, and 13 million diagnosed with AMD. It is estimated that less than half of those individuals with diabetes are screened periodically for DR. Lack of medical coverage and access to healthcare providers imposes major obstacles for nearly 10 million diabetics. Creating an affordable and accessible solution to providing screening services to these diabetics presents a significant challenge to the healthcare community. A comprehensive screening program for U.S. citizens utilizing ophthalmologists, optometrists, or other trained specialists, readers, to grade each case would be prohibitively expensive. The solution is to implement a computer-assisted technology similar to other medical applications, such as mammograms and Pap smears; that would provide comprehensive, periodic screening of our at-risk population. Our business models show a 400% decrease in costs with the integration of automation into today manual screening methods. The study will be made possible through the implementation of the infrastructure for a reading center in South Texas where it is estimated that nearly 200,000 diabetics reside and over 50% do not receive annual examinations. The center will be a demonstration site where the efficacy of the software can bedocumented for submission to the FDA for pre-market approval (PMA). The goal is to show that a center's through put number of cases screened per time period will increase fivefold through the use of a hybrid (automation-human graders) approach with sensitivity that is comparable or better than solely human-based screening. The significance of this proposed research is two-fold. First, by increasing the productivity of reading centers through automation, a much larger population of at-risk individuals willhave access to this service, leading to improved productivity and quality of life through early detection and treatment. Second, by providing to the FDA, a system that is highly effective and sensitive to advanced disease, the issue of safety is essentially eliminated. PUBLIC HEALTH RELEVANCE: Today, the CDC reports that there are about 80 million people in the US who have some form of eye disease. Diabetic retinopathy, age-related macular degeneration, and glaucoma are the leading causes of blindness. There is some form of intervention for each of these eye diseases that can result in the extension of useful vision, if detected early. Our automated eye disease screening system will make examination available to millions of Americans at risk for eye disease available without major impact on our healthcare system. This is possible only through automation as an adjunct to examinations by eye care specialists.

* Information listed above is at the time of submission. *

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