RetnaGene™ AMD is a laboratory developed test (LDT) to assess the risk of developing choroidal neovascularization (CNV), the wet form of age-related macular degeneration (AMD), a common eye disorder of the elderly that can lead to blindness.

• Pure genetic assessment with comprehensive markers
• Identifies at-risk Caucasians, age 60 and older
• Requires a cheek swab sample or blood sample
• Identifies patients as Low, Moderate or High Risk

A Genetic Test to Calculate Patient’s Risk

The test was designed to provide a comprehensive and accurate assessment of risk, based solely on genetic markers that are static through life and avoided inclusion of self-reported variables (e.g. smoking history) or non-static factors (BMI, education status) that might otherwise introduce inaccuracies in calculating a patient’s risk of disease.

Identifying an increased risk of developing wet AMD should help you tailor the management of your patients. This could potentially lead to improved detection of wet AMD at an earlier stage, before much vision loss has occurred.

The Lab Report

The Lab Report will indicate your patient’s Risk Score, and a comparative probability rating to indicate if your patient has a Low, Moderate, or High Risk of developing the wet form of age-related AMD.

The risk score and probability of developing CNV are determined based on the risk profiles and associated disease observed in a retrospective computer-modeled study.¹  The risk estimate is intended to reflect values expected in Caucasian patients of European ancestry age 60 and older.

The performance of this test has not been established in individuals of different races and age groups. Results should be considered in context with other clinical assessments.

Reference

1. Hageman GS, et al., Hum Genomics. 2011; 5(5).

The RetnaGene™ AMD LDT is covered by patent rights including but not limited to United States Patent Nos.: 7,867,727; 7,695,909; and pending published patent applications: US 20100330097; US 20100303832; US 20100216149; US 20090258822; US 20090111708; US 20090017029; US 20080152659; US 20080261211; US 20060281120; WO 2009059321; PCT/US2008/082285, and foreign counterparts thereof.

This test was developed and its performance characteristics determined by Sequenom Center for Molecular Medicine. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) as qualified to perform high complexity clinical laboratory testing.