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Firm creates key device

Rochester Business Journal
June 5, 2015

A University of Rochester Medical Center neurologist believes a device he has spent years developing could provide a long-sought key to preventing or delaying Alzheimer’s disease.

The device, Cognivue, whose first prototype Charles Duffy M.D. built with his son’s help in the family garage, soon could become standard equipment in primary care offices, Duffy believes.

CEO of Cerebral Assessment Systems Inc., a company he formed to produce and market the device, Cognivue could be on the verge of a breakout, Duffy said.

Cognivue does not promise to slow, roll back or halt dementia’s progress, unlike a string of hoped-for Alzheim-er’s treatments that drug companies have tested or introduced with at best limited success over the past few years.

Instead, the device runs a surprisingly simple test that could provide the first reliable way to detect Alzheimer’s and other dementias in their earliest stages. 

Funded by local angel investors—including Torvec Inc. CEO Richard Kaplan, who is CAS chairman—the firm employs four, including Duffy, who also maintains a UR Medicine clinical practice.

Cognivue has been evaluated positively by the Centers for Medicare and Medicaid’s Northeast region, Duffy said. Food and Drug Administration officials are weighing its application to be approved for U.S. sales.

If it wins FDA approval and other Medicare districts agree to reimburse doctors for administering Cognivue tests—developments Duffy sees as likely and possibly imminent—the device will be “an absolute blockbuster,” predicted Jay Birnbaum, a member of the Rochester Angel Network whom Kaplan recruited as a CAS financial backer.  

“Dick Kaplan called me about CAS seven years ago. I looked into it and the company met all the criteria for what I look for in an investment,” Birnbaum said.

A real estate developer and the owner of the Clover Street office building in Pittsford that houses CAS, Birnbaum sits on the fledgling company’s board. Among criteria he sees as crucial for an angel investment are a high gross margin product with potential to reach a wide market. 

Demographics virtually assure a wide market for dementia-related tests and treatments.

A predictor of Alzheimer’s and other dementias is age. And as the youngest of the more than 70 million strong U.S. baby boomer generation enters geriatric territory, experts say demand for dementia tests and remedies will spiral up.

Alzheimer’s is on the rise and will be “not just a burden on our health but a burden on our economy,” National Institutes of Health director Francis Collins M.D. warned in congressional testimony last year.

Without effective measures to deal with the disease, costs would rise dramatically, he said.

A 10-minute test
Duffy envisions Cognivue cognitive function screenings becoming as much a part of annual physicals and other primary care assessments as blood pressure tests. That would mean one or more of the devices becoming standard equipment in most of the tens of thousands of primary care offices that exist in the U.S. market alone.

Cognivue test takers sit in front of a computer screen and rotate a wheel to follow a series of prompts. The test takes around 10 minutes. UR owns two patents on technology underlying Cognivue. Duffy licensed them from the university and personally holds 16 more.

Much like a cholesterol or blood pressure screening, a Cognivue test yields a number. And just as blood pressure results tells physicians something about their patient’s heart health or stroke risk, Duffy said, a Cognivue number tells doctors something about patients’ mental functioning.

A caution: Cognivue results need to be interpreted by a physician who can put the number in context, factoring in information such as a patient’s age, general state of health and history, he added.

Properly interpreted Cognivue results can provide vital information that has never before been available, he said. Though patients might be years away from showing any outward sign of dementia, a Cognivue test can identify hidden changes before dementia begins to rob sufferers of their memories and irreversibly erode their very sense of self.

The FDA has approved three drugs to treat Alzheimer’s. There used to be four, but the FDA found one to be unsafe and rescinded its approval. That drug and the remaining three are capable of delivering only limited and temporary relief. None can halt the disease’s progress.

Over the past several years, major pharmaceutical firms have touted a string of nine Alzheimer’s drugs after seeing positive results in early-stage clinical trials only to see them fail in later trials or be pulled by the FDA over safety concerns. 

“Efforts to develop a treatment for this disease are coming up short because they are probably being used too late,” said URMC researcher Mark Mapstone in a 2014 interview.

Mapstone was lead author of a 2014 paper describing hopeful results of a study he has been conducting since 2007 to develop an Alzheimer’s blood test capable of catching the early stage by identifying a biomarker of the disease. He is a colleague of Duffy and did post-doctoral work under Duffy.

Mapstone sees Duffy’s Cognivue technology and the blood test he is working to develop as complementary and Cognivue as in some ways a superior tool.

Because it is rooted in and reveals behavioral changes rather than biological markers of dementia, Cognivue might yield results more useful to physicians and researchers, Mapstone said in an interview this week.

If a biological marker shows evidence of the disease, he asks, but the person tested shows no cognitive impairment, what is a doctor or a researcher to do with that evidence? A Cognivue result would provide a clear path to possible treatment and would help clinical researchers more accurately sift through results, Mapstone believes.

Another point he sees in Cognivue’s favor: The blood test he is researching is not nearly ready for prime time; Cognivue is close.

If the biomarker test pans out, it would not be cheap, said Michael Nazar M.D., a co-author of Mapstone’s 2014 paper who is aware of Duffy’s work.

A family medicine specialist who is also certified in geriatrics, Nazar maintains a small practice at St. Bernard’s Park, a local senior citizens’ apartment community. He is also a Rochester Regional Health vice president overseeing 50 primary care practices, some of which have been testing Cognivue as part of the FDA’s screening process.

Nazar looks cautiously at Duffy’s prediction of Cognivue becoming standard equipment in primary care offices.

There is nothing in data gathered so far to suggest Cognivue will not work as effectively as Duffy believes, Nazar said.

But other standard medical tests—PSA screening for prostate cancer and mammograms to test for breast cancer to name two—have proved to be double-edged swords, detecting non-aggressive disease that might be better left untreated as well as pointing to conditions that need treatment.

There is not yet enough data to say whether Cognivue might be prone to similar difficulties, Nazar said. Still, he added, if the device works as well as Duffy believes it does, it could be very widely used.

Two caveats: Cognivue would have to be affordable to financially pressed primary care practices and third-party payers would have to agree to reimburse doctors for Cognivue testing, Nazar said.

The device would be affordable, Duffy said. If Cognivue wins FDA and Medicare approval, the company is ready to move. 

CAS plans to offer primary care offices a month’s free trial and lease Cognivue systems to those that decide to keep it. This would let practices amortize the device’s cost without making a big, upfront investment, Duffy said.

While Duffy has been working with FDA and Medicare officials to shepherd Cognivue through the government agencies’ approval processes, CAS has made arrangements with a contract manufacturer that can turn out the devices. It also has been in talks with medical device manufacturers as potential partners capable of orchestrating widespread distribution.

Several device makers have expressed interest, Birnbaum said. And if FDA approval were to come through, their interest would rise considerably.

6/5/15 (c) 2015 Rochester Business Journal. To obtain permission to reprint this article, call 585-546-8303 or email

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