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Clinical investigators comment on their study of Cognoptix eye test designed to identify Alzheimer’s disease that showed strong results: 85% sensitivity and 95% specificity

ACTON, Mass., Sept. 30, 2013 — Cognoptix announced today the availability of an InfoVid containing brief interviews with two of the clinical investigators who participated in a multi-site clinical trial of its SAPPHIRE II eye test, designed to identify Alzheimer’s disease patients via a beta-amyloid (Ab) signature in their eyes.


By detecting a specific fluorescent signature of ligand-marked Ab in the supranucleus region of the human lens, SAPPHIRE II achieved a sensitivity of 85% and a specificity of 95% in differentiating 20 patients who were clinically diagnosed with probable Alzheimer’s Disease (AD) from a group of 20 age-matched healthy volunteers.

“The study results for the SAPPHIRE II eye test were very impressive,” said Carl Sadowsky, MD, FAAN, Medical Director, Premiere Research Institute, West Palm Beach, Fla., and a principal investigator in both the feasibility and pre-pivotal clinical trials of the SAPPHIRE eye test. “The 85% sensitivity of the SAPPHIRE II system is superior to the reported 80% sensitivity of PET (Positron Emission Tomography) imaging of the brain. In addition, the specificity of the SAPPHIRE II system, at 95%, is significantly superior to the reported 80% specificity for PET imaging.”

A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer to look for disease in the body. According to the Society of Nuclear Medicine and Molecular Imaging, a PET scan can cost up to $4,000, depending on the type of scan. The SAPPHIRE II eye test is expected to cost significantly less.

“The final study results revealing 85% sensitivity and 95% specificity identifying Alzheimer’s Disease patients via a beta-amyloid signature in their eyes is an amazing discovery,” added Gus Alva, MD, Medical Director, ATP Clinical Research, Costa Mesa, Calif., and a principal investigator in the pre-pivotal clinical trial of the SAPPHIRE II eye test.

SAPPHIRE II: Designed to Be a Reliable Eye Test for Early Detection of Alzheimer’s Disease

Cognoptix has developed an entirely novel, early-stage diagnostic for Alzheimer’s Disease (AD) to allow treatment before significant neuronal loss and irreversible brain damage occurs. Currently there is no early-stage diagnostic in the market today. Unfortunately, patients often incur up to 50% neuronal loss and a delay of up to two years before demonstrating severe enough symptoms to achieve diagnosis by the current gold standard: a ‘process of elimination’ of other possible diagnoses such as stroke, trauma, Parkinson’s disease, depression, etc., through extensive cognitive and physical testing. New therapeutic drugs to slow or stop the progress of AD are expected to reach the market soon.

Cognoptix has developed a method of early-stage diagnosis to allow treatment before significant neuronal loss and irreversible brain damage occurs. The Company’s technology is based on a scientific breakthrough by the founders: the discovery of abnormal deposits on the lens of the eye which involve the same Aβ peptide (Aβ 1-42) that is deposited in the brain and which is thought to be a cause of neuronal loss in Alzheimer’s disease. Through the post-mortem examination of Alzheimer’s patients, the founders confirmed this link and determined the presence of complete or partial circumferential deposit of protein aggregates in the supranuclear region of the lens of AD patients.

The Cognoptix SAPPHIRE II system consists of a laser-based reading device and consumable ophthalmic ointment. The eye exam can be given by a general practitioner and only takes a few minutes to achieve a result.

According to the Alzheimer’s Association, Alzheimer’s Disease is the sixth-leading cause of death in the United States: approximately 5.2 million persons are estimated to have AD and dementia, costing the U.S. more than $200 billion annually in medical and personal care expenses.

About Cognoptix

Cognoptix, a privately held medical technology company headquartered in Acton, Mass., is focused on developing and commercializing an in-office, drug/device diagnostic system as an aid in the early detection of Alzheimer’s Disease (AD). Its investors include Inventages Venture Capital, one of the world’s largest life sciences-, nutrition- and wellness-focused venture capital firms; Launchpad Venture Group, a Boston-based angel investment firm that provides funding to early-stage companies; and Maine Angels, accredited private equity investors in promising New England entrepreneurs and companies.

NOTE: The SAPPHIRE II system is approved for investigational use only in the United States.


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