Navigation Links
Arctic Reaffirms the Value of Genetic Testing for Age-Related Macular Degeneration
Date:11/15/2012

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.

(Logo: http://photos.prnewswire.com/prnh/20121115/DE14213LOGO)

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 in their first eye, even after two years of treatment(4). This same study demonstrated that patients treated earlier in the course of the disease maintained near-normal vision (20/63 or better) approximately 90% of the time. Subsequent peer-reviewed publications have reaffirmed the benefits of early treatment and surveillance for high-risk patients(5,6), and the 2008 AAO Preferred Practice Patterns have recommended that "patients at high risk may be examined more frequently in an effort to detect asymptomatic CNV at a treatable stage(7)."

Arctic is pleased to announce that substantive scientific advances from leading academic institutions are being incorporated into the next generation of the Macula Risk test, Macula Risk® NXG. Seven (7) novel markers from three large impactful bodies of work from the foremost researchers in this field(8,9,10), including the cholesterol metabolic markers (CETP, LPL, LIPC and ABCA1), the complement factor I gene (CFI) and the intracellular matrix genes (COL8A1 and TIMP3), are being added to the algorithm along with age, smoking, BMI and the clinical status of AMD. Validated risk determinations of two large and independent populations have demonstrated the ability of this model to accurately predict progression to advanced AMD within 10 years (AUC=0.895), with a sensitivity and specificity each greater than 80%3. This is a level of performance unprecedented in the field of AMD risk assessment.

About Arctic

ArcticDx Inc. is a molecular diagnostic company with expertise in the design, development and commercialization of validated molecular diagnostic tests. Our business model is focused towards the rapid commercialization of Intellectual Property (IP) from international gene discovery programs. We combine the work of academic strategic partners (i.e. Cancer Care Ontario ARCTIC project - Colorectal Cancer; University of Michigan - Macular Degeneration) with our international commercialization processes to bring the latest research in molecular diagnostics to healthcare providers.

(1) Stone E, et al. Recommendations for Genetic Testing of Inherited Eye Diseases: Report of the American Academy of Ophthalmology Task Force on Genetic Testing. Ophthalmology 2012;119:2408-2410

(2) Seddon J, et al. Prediction Model for Prevalence and Incidence of Advanced Age-Related Macular Degeneration Based on Genetic, Demographic and Environmental Variables. IOVS May 2009;50(5):2044-53

(3) Seddon J, et al. Prospective Assessment of Genetic Effects on Progression to Different Stages of Age-Related Macular Degeneration Using Multi-State Markov Models; IOVS, March 2012;53(3): 1548-1556

(4) Boyer D et al. Subgroup Analysis of the MARINA Study of Ranibizumab in Neovascular Age-Related Macula Degeneration, Ophthalmology 2007 Feb;114(2):246-52.

(5) Lim J, et al. Delay to Treatment and Visual Outcomes in Patients Treated with Anti-Vascular Endothelial Growth Factor for Age-Related Macular Degeneration. Am J Ophthalmol 2012;153(4):678-86 

(6) Maguire MG, et al. Complications of Age-related Macular Degeneration Prevention Trial (CAPT) Research Group. Characteristics of choroidal neovascularization in the complications of age-related macular degeneration prevention trial. Ophthalmology 2008;115:1468-73

(7) American Academy of Ophthalmology 2008 Preferred Practice Patterns (http://one.aao.org/CE/PracticeGuidelines/PPP.aspx?p=1)

(8) Neale BM, Fagerness J, Reynolds R, Sobrin L, Parker M, Raychaudhuri S, et al. Genome-wide association study of advanced age-related macular degeneration identifies a role of the hepatic lipase gene (LIPC). Proc Natl Acad Sci U S A. 2010;107(16):7395-400.

(9) ChenW,StambolianD,EdwardsAO,BranhamKE,OthmanM,JakobsdottirJ,etal.GeneticvariantsnearTIMP3andhigh- density lipoprotein-associated loci influence susceptibility to age-related macular degeneration. Proc Natl Acad Sci U S A. 2010;107(16):7401-6.

(10) Fagerness JA, Maller JB, Neale BM, Reynolds RC, Daly MJ, Seddon JM. Variation near complement factor I is associated with risk of advanced AMD. Eur J Hum Genet. 2009;17(1):100-4. 

 


'/>"/>
SOURCE ArcticDx Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Haemonetics Reports Second Quarter Fiscal 2013 Revenue Up 22%, Organic Revenue Up 6% and Adjusted EPS of $0.90, Reaffirms Fiscal 2013 Guidance and Announces Two-For-One Stock Split
2. Sequenom Addresses Preliminary Injunction Decision, Reaffirms Defense of Patent
3. Northwest Bio Reaffirms Its Freedom to Operate; Refutes Other Parties Misleading Patent Assertions
4. Biobetters in Key Markets - Opportunities for Biotechnology Companies to Sustain Innovation with Low Risk and High Value Offerings
5. Lung Cancer Survivors Share Stories of Value of Early Detection and Hope for More Effective Treatments
6. Medical Marijuana, Inc. Portfolio Company PhytoSPHERE Systems Announces Successful Production of Hemp Harvesting for High Value CBD Oil
7. Accountable Care and Value-Based Purchasing Drives Adoption of Advanced Solutions for Health Data Analytics, Finds Frost & Sullivan
8. New Approach to Growing Waste to Value Industry in United States
9. Online Training for Hospital Value Based Purchasing Now Available
10. Theravalues Confirms Beneficial Effects of Theracurminâ„¢ on Diastolic Function in Hypertensive Patients
11. NIH Awards New England Biolabs a Phase II SBIR Grant for the Research and Development of Novel Enzymes for Epigenetic Studies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2017)... USA, and CARDIFF, UK (PRWEB) , ... June 23, 2017 , ... ... (LANL), and Brian Lula, president of Physik Instrumente USA, have been selected as this ... and photonics . , The two have been invited along with other honorees to ...
(Date:6/23/2017)... ... June 23, 2017 , ... ... flying hobbyists, and the University Aviation Association (UAA), the unifying voice for collegiate ... Collegiate Challenge will encourage teamwork, competition, and success through a STEM-based education platform. ...
(Date:6/22/2017)... Colorado (PRWEB) , ... June 21, 2017 , ... ... RTP regional office in North Carolina, and engages Timothy Reinhardt to manage the ... of quality leadership at Pfizer Inc, with his most recent role as the ...
(Date:6/22/2017)... ... June 22, 2017 , ... AESKU.GROUP, an innovation ... Systeme & Technologien GmbH, thereby expanding its product portfolio to include allergy and ... urticaria, asthma, atopic eczema or a food allergy. Allergies are escalating to epidemic ...
Breaking Biology Technology:
(Date:4/19/2017)... York , April 19, 2017 ... as its vendor landscape is marked by the presence ... market is however held by five major players - ... Together these companies accounted for nearly 61% of the ... the leading companies in the global military biometrics market ...
(Date:4/11/2017)... 11, 2017 Crossmatch®, a globally-recognized leader ... today announced that it has been awarded a ... Activity (IARPA) to develop next-generation Presentation Attack Detection ... "Innovation has been a driving force within Crossmatch ... allow us to innovate and develop new technologies ...
(Date:4/5/2017)... , April 5, 2017  The Allen Institute ... Allen Cell Explorer: a one-of-a-kind portal and dynamic digital ... 3D imaging data, the first application of deep learning ... human stem cell lines and a growing suite of ... platform for these and future publicly available resources created ...
Breaking Biology News(10 mins):