Devices & Diagnostics, Diagnostics, Startups

Startup aims to diagnose Alzheimer’s through simple eye test; raises $15M

Confirming an Alzheimer’s diagnosis today takes a multi-pronged approach: Doctors evaluate a patient’s mood and […]

Confirming an Alzheimer’s diagnosis today takes a multi-pronged approach: Doctors evaluate a patient’s mood and cognition, conduct basic neurological tests and perform brain imaging scans to gauge a patient’s likelihood of having the devastating disease.

A Massachusetts startup is circumventing this time-consuming process by developing a quick, in-office eye test for the early diagnosis of Alzheimer’s disease. Cognoptix has raised more than $15 million in a Series D round, the company says, to test its test in late-stage clinical trials.

Cognoptix’s optical scanning machine, called the Sapphire II, can detect beta amyloid in a person’s eyes. Beta amyloid is a substance that builds up in the brains of patients with Alzheimer’s; it also aggregates in the lens, and its levels can be monitored non-invasively by a primary care physician with the simple eye test. The doctor just drops a beta amyloid-specific fluorescent dye into the patient’s eyes, and the likelihood of his or her having the disease is spun out of the machine.

“If binding increases over time, a positive diagnosis can be made, enabling clinicians to track the progress of the disease in patients by measuring levels of fluorescence – as well as potentially enabling doctors and pharmaceutical researchers to monitor the efficacy of Alzheimer’s drugs in clinical trial settings,” the company said.

The test indicates with 95 percent specificity that the patient have Alzheimer’s, the company says. By contrast, PET imaging has only 80 percent specificity in gauging whether a patient has Alzheimer’s. It’s been tested in a small Phase II trial of 40; the funding influx is meant to pay for a larger clinical study.

The technology comes from two physicians, Dr. Lee Goldstein and Dr. Leo Chylack, at Brigham and Women’s Hospital in Boston. The round was led by new investor Alopexx, along with original investor Launchpad Venture Group. The device is only approved for investigational use in the U.S. thus far.

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