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Frequently Asked Questions On Macular Degeneration

 
 
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If I know I have a Family History of AMD, what additional benefits will this test provide?

Awareness of family history is only a portion of the knowledge

  • Family history is a poor predictor of individual risk
    • Patients are unlikely to have the same genetic variation as his/her parents or siblings

Issues With Family History

  • Only helpful if positive
  • Dependent on number and age of family members
  • Changes with time
  • Your true and individual risk is best assessed with a comprehensive Age-Related Macular Degeneration Test and Risk Assessment
    • The Visible Genomics’ AMD Risk Assessments combines a patient’s genetic status, ocular findings, demographic and lifestyle characteristics to deliver a comprehensive and clinically actionable risk assessment.

Personalized Management can help your physician determine the best personalized management plan for you with outcome goals of:

  • Preventing or Limiting Vision Loss
  • Delaying the onset of AMD with primary prevention (i.e. Primary prevention includes those measures that prevent the onset of illness before the disease process begins.)
  • Delaying the progression of AMD with secondary prevention (i.e. Secondary Prevention - trying to detect a disease early and prevent it from getting worse.)
  • Allows us to take a proactive personalized approach in prevention or delaying AMD

I do not have any known Family History of AMD, what benefit does this test provide me?

  • AMD is caused by both genetic and non-genetic factors. Awareness of disease risk can give you piece of mind, heightened awareness, or provide the motivation for living a healthy lifestyle which leads to decrease AMD risk.
  • You can get AMD without having a family history of disease
  • You may have risk factors that can cause AMD: elderly, high BMI (>25), smoker, high fat diet, UV light
  • Detecting early AMD is very difficult and often is not identified until the intermediate stage. A heightened awareness of risk can help with early detection leading to earlier intervention, leading to limited or no vision loss. The earlier AMD is treated the better the outcomes.

What would you do differently from a clinical management standpoint with these results?

  • Your doctor will put you on an individual management and treatment plan that is personalized to your results.
  • This genetic age-related macular degeneration test alone will not determine your treatment plan. The test along with other clinical and lifestyle factors will help determine the best course.

For Example,

  • If you are at low risk the doctor may just ensure you keep doing what you are doing and come in for your annual exam.
  • However, if the doctor finds that you are at high risk, they may recommend more frequent exams, advanced testing/imaging, and a vitamin treatment regime. Surveillance will be very important in this scenario. Your doctormay want to follow you closely, so you don’t progress towards advanced disease without further intervention. Typically, the earlier the intervention the better the outcomes, even in advanced cases.

Will my Insurance cover this?

  • Visible Genomics age-related macular degeneration testing, although it is not generally covered by insurance, it is affordable and can be paid for by using HSA/FSA. We can also provide you with the information needed to submit the expense to your Insurance for possible reimbursement. Currently there is no formal Medicare or Private Insurance coverage for this type of testing.
  • Other procedures related to the risk assessment could also be potentially covered: Sample collection procedure, Dilated Fundus Examination, Results review and counseling

How does this compare to 23andMe?

  • The Visible Genomics’ AMD Risk Assessments combines a patient’s genetic status, ocular findings, demographic and lifestyle characteristics to deliver a comprehensive and clinically actionable risk assessment and clinical report.
  • 23andMe only looks at 2 genetic markers and provides no individualized interpretation or report.

How accurate is the age-related macular degeneration test?

  • The Visible AMD Risk Assessment’s performance is reported as a feature called Area Under the Curve(AUC). The AUC generally varies between 0.5, indicating a model with a predictive power no better than chance, and 1.0, indicating a perfect model (Janssens et al., 2007). Models are expected to have an AUC > 0.75 for informative screening of individuals who are at increased disease risk (Janssens et al., 2007). The higher the AUC, the more precise the prediction and thus, the greater the clinical utility of the combination of factors included in the model. AUC is a combination of sensitivity and specificity Cooke Bailey, J.N., and Igo, R.P. Jr., 2016. Genetic risk scores. Curr. Protoc. Hum. Genet. 91:1.29.1-1.29.9).
  • The performance of the Visible AMD Risk Assessment at 2, 5 & 10-year AUC= 0.87. This means that the predictive power of the Assessment is clinically validated to predict the patient’s individual risk of advanced AMD over the next 2, 5 and 10 years.
  • As a comparison, below are two currently available commercial tests for other diseases:
    • BRCA (breast cancer) genetic risk test*: AUC= 0.74 to 0.78
    • Prostate cancer genetic risk test**:
    • AUC= 0.77 to 0.82

How is the test performed?

  • This non-invasive age-related macular degeneration test is performed through a simple and convenient in-office cheek swab. The patient or clinician can do the collection. Sample is sent to the lab and results are sent back to the physician who ordered the test. The collection process takes about 1 minute. Submitting the sample takes ~10 minutes for the physician’s office.

What do you do with my data and sample?

  • Visible Genomics keeps all data in a HIPPA complaint and secured database. Samples are deidentified and stored anonymously. Any anonymous data is kept for both R&D and Quality Assurance/Quality Control purposes. Visible also keeps data in case you decide to take the test again. We can compare results from one year to another.

How long will it take to get my results?

  • You will be notified when your results are in. They will receive your age-related macular degeneration test results and contact you for review. Typically, it takes 2-4 weeks for your results to be returned to your doctor once Visible receives your samples at the lab. A follow up appointment will be scheduled where your doctor will review your results with you in detail and determine the best personalized management plan for you.