In January 2014, Cognoptix announced the strong results of 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.
The study used a fluorescent ligand eye scanning technique in 20 patients who were clinically diagnosed with probable Alzheimer’s Disease and 20 patients without the disease, according to the study.
The Sapphire II eye test demonstrated a sensitivity of 85 percent and a specificity of 95 percent by differentiating the patients via the detection of a beta-amyloid signature in their eyes, according to the press release.
The results validate a previous clinical trial of the Cognoptix drug/device combination eye test.
“This simple SAPPHIRE eye test has the potential to change the way that Alzheimer’s disease is detected and managed,” 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 Sapphire II has been classified as a device/drug combination product by the U.S. Food and Drug Administration. It consists of a laser-based reading device and a consumable ophthalmic ointment, according to Cognoptix.
As reported in the press release, the Sapphire II testing system is approved only for investigational use in the U.S.