TORONTO, Nov. 15, 2012 /PRNewswire/ -- In response to the November 11, 2012 press release issued by the American Academy of Ophthalmology (AAO) Task Force on Genetic Testing, ArcticDx Inc. (Arctic) maintains that Macula Risk®, its laboratory developed test (LDT) for AMD, is of the highest standard and proven to add to the accuracy of clinical assessment alone in its intended use of risk stratification for AMD patients. While in general agreement with the Task Force's Recommendations for Genetic Testing, re-published in the November issue of Ophthalmology(1), Arctic holds that the accompanying statement ("current genetic tests for AMD are flawed") is invalid and potentially detrimental to patients with advancing disease who could benefit from increased surveillance leading to earlier treatment.
Arctic reaffirms its support for the Recommendations, which discourage against routine genetic testing and direct-to-consumer marketing of genetic tests for complex eye disorders such as age-related macular degeneration (AMD) and late-onset primary open angle glaucoma. Macula Risk is only available through a qualified eye care practitioner, and is recommended for selective use in combination with clinical findings from a comprehensive eye exam to evaluate a patient's risk of progression from early and intermediate AMD to advanced AMD with vision loss.
Arctic maintains that surveillance strategies are of benefit to individuals at high-risk for AMD progression, and nothing has been proven to be more accurate in predicting risk of AMD progression than the combination of genetics with the clinical assessment of an AMD patient(2,3). A subgroup analysis of the pivotal MARINA Study for ranibizumab in 2007 demonstrated that more than half (53%) of patients treated for wet AMD failed to maintain functional vision
|SOURCE ArcticDx Inc.|
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