Nicox and Sequenom announce the launch of expanded access to RetnaGene™ test portfolio in the U.S.
June 19, 2014
Sophia Antipolis, France and San Diego, Calif.
Nicox S.A. (NYSE Euronext Paris: COX), the international ophthalmic company, and Sequenom, Inc. (NASDAQ:SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that Nicox’s subsidiary, Nicox Inc. is launching expanded access to Sequenom Laboratories’ RetnaGene™ portfolio of laboratory-developed genetic tests in the United States (U.S.). The RetnaGene portfolio includes RetnaGene AMD and RetnaGene LR, specialized genetic tests, which assess an individual’s risk for advanced age-related macular degeneration (AMD).
“Expanding access to the RetnaGene portfolio of tests is an important milestone in the progress of the Nicox Ophthalmic Diagnostics franchise in the U.S.,” commented Jerry St. Peter, Executive Vice President and General Manager of Nicox Inc. “AMD is a leading cause of blindness in the U.S. and is estimated to affect over 15 million Americans, including 10 to 15% suffering from an advanced form of the disease.1,2 The RetnaGene tests allow for improved patient management, by examining the most relevant genetic markers for a more accurate prediction of advanced AMD risk. Both the RetnaGene tests and our groundbreaking test for the early detection of Sjögren’s syndrome, Sjö™, will be supported by our rapidly expanding specialist sales force.”
RetnaGene™ – A portfolio of laboratory-developed tests that advances AMD risk assessment
AMD is the most common cause of visual impairment and the leading cause of blindness in the elderly population in the developed world. The RetnaGene portfolio includes two laboratory-developed genetic tests performed exclusively by Sequenom Laboratories that evaluate an individual’s risk of advanced AMD. The RetnaGene AMD test assesses the risk for wet AMD (also called choroidal neovascularization, CNV) within two, five and ten years in patients aged 55 and older with early or intermediate dry AMD. The RetnaGene™ LR test assesses the lifetime risk of advanced AMD (wet or dry) in patients who have not been diagnosed with AMD, aged 55 and older and/or with a family history of AMD. The RetnaGene tests evaluate genotype and other known risk factors, giving a more complete assessment of a patient’s individual risk for developing advanced AMD than with current phenotype-based standards.
“Currently there is much debate in the medical community surrounding the best way to incorporate genetic testing for AMD into clinical practice. Expanded access to the RetnaGene tests will provide broader use and education to clinicians about this important technology,” said Quan Dong Nguyen, MD, MSc, who holds the McGaw Memorial Endowed Chair in Ophthalmology and is the Inaugural Director of the Truhlsen Eye Institute, University of Nebraska Medical Center.
We believe the new offering of the RetnaGene tests by Nicox will help to fuel the momentum in the field while also developing enhanced opportunities for clinical trials and research to continue to investigate the utility of genetic testing services for AMD,” said Diana Do, MD, Associate Professor of Ophthalmology and Director of the Carl Camras Center for Innovative Clinical Research in Ophthalmology at the Truhlsen Eye Institute, University of Nebraska Medical Center.
Both RetnaGene tests offer a quick and simple method for collecting DNA specimens with an easy-to-use in-office buccal swab. The RetnaGene tests were developed, validated and are performed exclusively by Sequenom Laboratories and are available through contract with Nicox. U.S. eye care practitioners can obtain more information and order specimen collection materials for the RetnaGene test by calling +1.855.MY.NICOX (+1.855.696.4269). Additional information can be found on Nicox’s new website specifically intended for a U.S. audience: www.mynicox.com. The Nicox Inc. team will be available at the Optometry’s Meeting® (117th Annual AOA Congress & 44th Annual AOSA Conference) being held from June 25 to 29, 2014 in Philadelphia, Pennsylvania, to discuss its ophthalmic diagnostics offering, including RetnaGene™ and Sjö™ (booth number: 1630).
“We are pleased with the timely progress of our partnership with Nicox and we are confident in Nicox’s ability to successfully expand access to the RetnaGene portfolio of tests in the ophthalmic arena in the U.S.,” stated William Welch, Chief Executive Officer of Sequenom, Inc.
About AMD, a leading cause of blindness in the U.S.
AMD is an insidious, progressive eye disorder that starts with relatively harmless tiny yellow deposits on the retina (the light sensitive tissue in the eye) and increases in prevalence and severity with age. It is estimated that AMD currently affects approximately 15 million people in the United States and is a leading cause of vision loss in Americans aged 60 and over.1 Advanced AMD represents 10 to 15 percent of all AMD cases and is estimated to affect at least 1.75 million patients in the U.S.2
Geographic atrophy is considered the advanced stage of the dry form of AMD. Another advanced form of AMD is neovascular or ‘wet AMD’, which causes profound loss of central vision and is the leading source of legal blindness in people over age 50 in the developed world. Wet AMD is caused by abnormal growth of fragile and leaky blood vessels, known as choroidal neovascularization (CNV) in the macula (a small area where vision is keenest at the center of the retina) in response to chronic inflammatory stress.
Genetics are highly influential in the development of AMD, with up to 71 percent of heritability for advanced AMD.3 The advanced “wet” form of the disease accounts for approximately 90 percent of severe vision loss associated with the disease.4,5 Conversion to wet AMD can be sudden, with vision loss being rapid and severe. A missed conversion can lead to delayed therapeutic intervention and the potential for irreversible central vision loss. On the contrary, an early risk assessment may enable patients to benefit from a personalized patient management plan with the goal of preserving vision.
Exclusive agreement between Nicox Inc. and Sequenom Laboratories for RetnaGene
Under the terms of the agreement signed in January 2014, Sequenom’s affiliate Sequenom Laboratories granted Nicox Inc. exclusive rights to promote the RetnaGene AMD and RetnaGene LR laboratory-developed tests to eye care practitioners in North America (United States, Canada, Puerto Rico and Mexico) and co-exclusive rights towards specialized retina physicians. Sequenom Laboratories provides the sample collection materials and performs the testing exclusively in its CLIA-certified laboratory at an agreed price to Nicox. Further, Sequenom Laboratories contributes existing commercial and clinical expertise, and marketing intelligence to expedite increased market demand and uptake within the general ophthalmology and optometry segments. Nicox is responsible for all marketing and promotional activities, and is directly promoting the RetnaGene tests to eye care practitioners.
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