September 24, 2013
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Ocular test for Alzheimer’s shows high sensitivity, specificity

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The Sapphire II test by Cognoptix showed a sensitivity of 85% and specificity of 95% in differentiating 20 patients diagnosed with probable Alzheimer’s disease from a group of 20 age-matched controls, according to a company press release.

The Sapphire II is an in-office, drug/device diagnostic system designed as an aid in the early detection of Alzheimer’s disease pathology. A ligand or contrast agent and software-controlled optical instrument allows for noninvasive detection and assessment of Alzheimer’s by measuring its hallmark, beta amyloid, in the supranuclear region of the lens of the eye.

The company reported that, in this study, the Sapphire II “showed excellent correlation to PET amyloid brain imaging.”

“Today, only about 5% of patients in the U.S. are diagnosed by Alzheimer’s specialists, and the remainder are diagnosed by nonspecialists,” 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, said in the release. “Therefore, providing a technology capable of improving the diagnostic sensitivity and specificity of Alzheimer’s disease for the nonspecialist will vastly improve the standard of care for patients with the disease.”

“These clinical results give us a great deal of hope that we will eventually be able to intervene early in the course of Alzheimer’s disease, well ahead of the manifestation of symptoms,” Maria C. Carrillo, PhD, vice president, medical and scientific relations, Alzheimer’s Association, said in the release.