Sample Report

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Below is a complete sample report based on real test output. Your report will contain your personal genetic data and individualized recommendations.

Report ®

Phone: 866.964.5182

Fax: 866.964.5184

Patient Name

–––––, –––

DOB

August 19, 1943

Gender

M

Accession

5008217

Specimen Type

Buccal Sample

Age

82

Collection Date

April 02, 2026

Receipt Date

April 07, 2026

Patient Genotype Group

GTG2

10-Year Risk for Progression to CNV or GA

0255075100TIME (Years)PROGRESSION RISK (%)251018%31%53%PatientPopulation Average

Progression Risk to CNV or GA

18%

2-Year

31%

5-Year

53%

10-Year

Genetic Risk Percentile

Patient's value: 36

LOW
0255075100
HIGH

Average Risk

Supplement Recommendation based on CFH and ARMS2 genotyping*

AREDS without Zinc

Genetic Features

GeneSNPResultRisk
CFHrs3766405CC**
CFHrs412852CC**
ABCA1rs1883025CC**
APOErs7412CC-
APOErs429358CT*
ARMS2rs10490924GG-
C2rs9332739GG**
C3rs2230199CC-
CETPrs3764261CC-
CFBrs541862AA-
CFIrs10033900CT*
COL8A1rs13095226TT-
LIPCrs10468017CT*
TIMP3rs9621532AA**
Risk Legend:- Low* Medium** High

Non Genetic Features

Risk ParameterValue
AMD Status ODEarly AMD
AMD Status OSEarly AMD
SmokingQuit
EducationHigh School or Greater
Height6' 2"
Weight220
BMI28

*Results and interpretation protected by US Patent US-9896728-B2

Page 2

About

This test is a combined prognostic and pharmacogenetic DNA test designed to determine a patient's risk of progression to advanced Age-related Macular Degeneration (AMD) and aid in the selection of appropriate eye supplement therapies based on a patient's individual genetic risk profile. Based upon a patient's combined genotypes at certain CFH and ARMS2 loci, the supplement shown to afford the greatest reduction in the 7-year rate of progression to advanced AMD for their genotype is recommended[1,2,3]. The use of CFH and ARMS2 genotypes can identify 1/6 people who experience twice the risk of progression to choroidal neovascular disease if exposed to daily AREDS zinc supplements (1,2,3). It also identifies those who benefit significantly from zinc prophylaxis. The use of genotypes to select supplements is proprietary and protected by an issued US Patent which has been licensed exclusively to the company. This reflects our pioneering efforts in genetics, AMD and selecting appropriate zinc exposures.

AMD Prognostic Result Interpretation

The prognostic result within the test combines SNP genotyping with phenotype and environmental factors to predict a patient's risk of progression to geographic atrophy (GA) or choroidal neovascularization (CNV), at 2, 5 and 10 years (4). Reported risk scores are calculated utilizing a Cox regression model for AMD progression derived from an analysis of samples from the National Eye Institute (NEI) Age-Related Eye Disease Study (AREDS) (5). The variables used in this risk calculation include the patient's genotype at 14 AMD-associated SNPs, the current AMD status in both eyes according to the Clinical Age-Related Maculopathy Staging (CARMS) System, age, smoking history, education level and body mass index (BMI). The Genetic Risk for each patient is expressed as a multiple of the amount of AMD genetic risk observed in an average US Caucasian population. This reflects the inherited baseline risk which remains constant throughout an individual's lifetime. Although an individual may have a high genetic risk, their absolute risk of progression over 10 years may be low if they have no clinical disease features. NOTE: Education level is assumed to be High School or equivalent for this score determination if not otherwise specified on the test requisition form. If patient height and weight were not provided, Body Mass Index (BMI) is assumed to be the U.S. average, 26.6 for males and 26.5 for females (Source: CDC), for this score determination.

Genotype Reference

GeneSNPLow RiskMedium RiskHigh Risk
CFHrs3766405 / rs412852 haplotypesAll othersCC/CT or CT/CTCC/CC
CFIrs10033900CCCTTT
C3rs2230199CCCGGG
C2rs9332739CCCGGG
CFBrs541862GGAGAA
LIPCrs10468017TTCTCC
ABCA1rs1883025TTTCCC
CETPrs3764261CCCAAA
COL8A1rs13095226CCTCTT
APOErs7412 / rs429358 haplotypesCC/CCAll othersTT/TT
TIMP3rs9621532CCCAAA
ARMS2rs10490924GGGTTT

Note: This table is for reference purposes, and is not part of the Macula Risk report

Description of Test Procedure

DNA was isolated from the patient's buccal swab specimen and the 14 genetic regions associated with AMD were amplified using quantitative polymerase chain reaction (PCR).

CFH / ARMS2 Genotype Groups

CFH Risk alleles
012
0 ARMS2GTG1GTG1GTG2
1 ARMS2GTG3GTG3GTG4
2 ARMS2GTG3GTG3GTG4

Test Limitations

The Test has been developed using strict quality assurance guidelines; however, the chance of a false result due to laboratory errors incurred during any phase of testing cannot be completely excluded. If insufficient quality or quantity of DNA was extracted from the specimen the testing may not be completed. Rare single nucleotide polymorphisms in the primer/probe annealing regions could interfere with the performance of this test. The test will not detect DNA sequence variations or abnormalities other than those stipulated in this report, and interpretation of the clinical significance of the reported sequence variations applies only to prediction of risk for advanced AMD and vitamin/mineral prophylaxis has not been validated for AMD risk progression in non-Caucasian populations.

Compliance Statement

Macula Risk genetic determinations are performed by Dynacare Inc. a COLA- and Ontario Provincial Ministry of Health-certified molecular testing laboratory, owned and operated by LabCorp inc.. The technical performance specification of the test were established by this reference testing facility through rigorous validation testing and satisfy the Canadian requirements for use in clinical decision making. CLIA licensure for this reference laboratory is pending and for this reason, results received by US practitioners during this period must be considered to be "for Research Use Only (RUO)" and for this reason alone, should not be relied on for making clinical decisions.

References

1. Vavvas DG, Small KW, Awh CC, Zanke BW, Tibshirani RJ, Kustra R. CFH and ARMS2 genetic risk determines progression to neovascular age-related macular degeneration after antioxidant and zinc supplementation. Proc Natl Acad Sci U S A. 2018 Jan 23;115(4)

2. Awh CC, Hawken S, Zanke BW. Treatment response to antioxidants and zinc based on CFH and ARMS2 genetic risk allele number in the Age-Related Eye Disease Study. Ophthalmology. 2015 Jan;12(1):162.

3. Awh CC, Lane AM, Hawken S, Zanke, B, Kim, I. CFH and ARMS2 genetic polymorphisms predict response to antioxidants and zinc in patients with age-related macular degeneration. Ophthalmology 2013;120(11):2317-23.

4. Seddon JM, Rosner B. Validated Prediction Models for Macular Degeneration Progression and Predictors of Visual Acuity Loss Identify High-Risk Individuals. Am J Ophthalmol. 2019 Feb;198:223-261.

5. Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001, Oct;119(10):1417-36.

Final

Accession Number: 5008217

Patient Name: –––––, –––

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