ArcticDX Inc

July 07, 2014 09:30 ET

Groundbreaking Genetic Tests for Age Related Macular Degeneration Now Available Through Canadian Eye Care Professionals

TORONTO, ONTARIO--(Marketwired - July 7, 2014) - AMD Insight Inc. announced today that it has licensed the exclusive Canadian commercial rights to Macula Risk® PGx from the test's developer, ArcticDx Inc. Macula Risk ® PGx 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 vitamin formulations for AMD based on his or her individual genetic risk profile.

AMD is the leading cause of vision loss in Caucasians over the age of 55. There are two types of AMD - "dry", or non-exudative, and "wet", or exudative. AMD causes damage to the macula - the light-sensitive cells at the center of the retina at the back of the eye. The macula is responsible for our ability to see with enough detail to read, drive, watch television and perform other activities that require focused, straight-ahead vision, as well as providing information that allows us to perceive colors; thus, allowing one to maintain independence in daily activities. Approximately one in ten Caucasians will lose vision from AMD.1 Progression to vision loss can be prevented if the disease is diagnosed and treated early. Unfortunately, up to 80% of advanced cases are diagnosed and referred to a specialist only in the later stages of the disease where permanent vision loss is likely.2 Furthermore, recent scientific literature suggests that patients taking high-dose eye supplements for AMD may be taking a formula that is consequently accelerating the onset of vision loss due to their unique genetic profile.

Macula Risk® PGx has two important components:

1. Macula Risk PGx prognostic testing - Approximately 20% of patients diagnosed with the dry form of AMD will progress to advanced AMD with vision loss. This progression may be prevented if the high-risk AMD patient is identified early, treated appropriately, and referred to a retina specialist earlier. Macula Risk PGx is up to 89.5% accurate at identifying those high-risk AMD patients who will lose vision within the next 2, 5 or 10 years.6 This allows primary eye care professionals an opportunity to manage these patients and refer them earlier.

2. Vita Risk pharmacogenetic testing - According to the U.S. National Eye Institute, high-dose eye vitamins with zinc are the standard treatment for patients with moderate dry AMD.3,4 However, a recent article published in the Journal of the American Academy of Ophthalmology, demonstrated that these treatments may be either helpful or harmful depending on the genetic profile of the patient.5 Macula Risk PGx determines the safest and most effective formulation for AMD patients based on their genotype. Vita Risk may also be ordered as a component of Macula Risk PGx or as a separate test.

"We are very excited to be able to now provide Canadian eye care professionals with an effective prognostic tool that can identify those patients who are at risk for AMD before any irreparable vision loss can occur. AMD is a debilitating disease that causes loss of central vision; the vision we rely on to read, to drive, to maintain our overall independence as we age," said Milka Cucuz, VP of Sales and Marketing for AMD Insight. "Early diagnosis and treatment is crucial for maintaining eyesight in patients with AMD. Macula Risk PGx is a critical tool that enables doctors to customize optimal therapy programs for their patients."

"There are many new technologies that have evolved to diagnose and treat AMD over the past ten years," commented Greg Hines, President and CEO of ArcticDx. "Improvements in treatments for both Dry and Wet AMD are available. New imaging technologies for the eye allow the doctor to diagnose this disease more accurately. Combining Macula Risk PGx with these technologies to stratify patients for disease management will improve outcomes."

Macula Risk PGx and Vita Risk are available as a simple cheek swab taken by the eye doctor. Testing supplies are available to eye care professionals at 1-866-964-5182 or email to customerservice@macularisk.com or on our website; www.macularisk.com.

About AMD Insight Inc.

AMD Insight is a privately owned Canadian company headquartered in Toronto, Ontario. The company focuses on genetic testing for AMD and making it available within Canada. The company also concentrates their efforts on attaining novel technologies that help detect, diagnose, and manage AMD patients.

About ArcticDx Inc.

ArcticDx is a privately owned molecular diagnostic company that commercializes validated genetic markers for Age-related Macular Degeneration. Its patent portfolio includes genetic marker patents either licensed exclusively from university research institutions or invented internally by the Company. ArcticDx has a CLIA-regulated laboratory in Grand Rapids, Michigan that has provided tens of thousands of AMD genetic tests for eye care professionals in the United States over the last five years. The Company has leadership experience in the development and commercialization of healthcare products including pharmaceuticals and molecular diagnostic tests.

  1. NEI web site: http://www.nei.nih.gov/health/maculardegen/index.asp
  2. Timothy W. Olsen, MD, Xiao Feng, MD, Terrance J. Kasper, MD, Pamela P. Rath, MD, Eric R. Steuer, MD, PhD: Fluorescein Angiographic Lesion Type Frequency in Neovascular Age-Related Macular Degeneration; Ophthalmology, 2004. 111(2): p. 250-5.
  3. Age-Related Eye Disease Study Research Group; National Eye Institute; 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/VOL 119, OCT 2001
  4. Age-Related Eye Disease Study Research Group; National Eye Institute; Lutein + Zeaxanthin and Omega-3 Fatty Acids for Age-Related Macular Degeneration; JAMA, Published online May 5, 2013
  5. Carl Awh; Anne Marie Lane; Steven Hawken; Brent Zanke; Ivana K Kim: CFH and ARMS2 genetic polymorphisms predict response to antioxidants and zinc in patients with age-related macular degeneration; Ophthalmology (in Press) August 2013
  6. Yi Yu, Robyn Reynolds, Bernard Rosner, Mark J. Daly, and Johanna M. Seddon: Prospective Assessment of Genetic Effects on Progression to Different Stages of Age-Related Macular Degeneration Using Multistate Markov Models; Investigative Ophthalmology & Visual Science, March 2012, Vol. 53, No. 3

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