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Embic Preps for Explosion in Alzheimer’s Tests

Embic Corp. is turning into an overnight success story that’s been 20 years in the making.
The Newport Beach-based provider of cognitive tests has benefited from a recent Food and Drug Administration approval for a new drug to treat Alzheimer’s disease.

“This whole space was stagnant,” Chief Executive Dennis Fortier told the Business Journal.

“Once approval came, demand for detection of memory loss exploded.”

Embic has developed a 10-minute noninvasive test that it says is 97% accurate to determine if a person is aging normally or if there are early signs of Alzheimer’s disease or other medical conditions that impair memory.

In prior years, the test wasn’t in high demand because doctors didn’t have effective medication to treat Alzheimer’s disease or patients who didn’t want to know.

That all changed when the FDA last July approved the first-ever disease-modifying treatment for Alzheimer’s disease called Leqembi, which was made by Biogen Inc. in conjunction with Japanese drugmaker Eisai.

Furthermore, Eli Lilly is expected to win FDA approval in the coming weeks for its Alzheimer’s medication called Donanemab, Fortier said.

“It’s very good news for a space that deserves serious attention,” Fortier said.

Embic, which counts 12 local workers, is part of this week’s Business Journal list of medical diagnostics and testing companies; see page 31 for more.

Neuroinformatics

Embic provided 50,000 tests last year and is preparing to “dramatically” increase the number this year by hiring a seasoned commercialization team and beginning a pilot direct-to-consumer program with a telehealth component.

It’s also responding to increasing demand from biopharmaceutical companies commercializing treatment for early-stage Alzheimer’s disease who need help to efficiently identify a deeper pool of clinical trial candidates in a faster and more cost-effective manner.

The company, which is currently raising funds, has received interest from “strategic investors,” i.e. large companies that may invest or buy it.

Embic officials say the company is already profitable and has a scalable program.

It’s planning to double its headcount and will expand beyond of its current location at the Pickup Family Neurosciences Institute at the Hoag Memorial Hospital Presbyterian in Newport Beach.

Embic calls itself a “neuroinformatics company” using advanced analytics to combine mathematical models with data from cognitive tests to precisely characterize overall brain health.

The company says its proprietary ability to quantify encoding and retrieval processes can resolve urgent problems in multiple healthcare channels. The company’s name is partly an acronym for metrics and biomarkers of cognition.

Embic recently presented its latest research on digital cognitive biomarkers at the Clinical Trials on Alzheimer’s Disease Conference.

The company was founded in 1999 by Chief Medical Officer Dr. William Shankle and Chief Scientific Officer Dr. Junko Hara.

Shankle was the founding clinical director of the Alzheimer’s Disease Research Center at University of California, Irvine, one of 30 such centers nationwide and who also holds the Judy & Richard Voltmer Endowed Chair in Memory and Cognitive Disorders at Hoag. Hara, a native of Japan, has a Ph.D. in computer science.

Industry Veteran

Prior to Embic, Fortier worked for eye health giant Bausch & Lomb, including locations in Italy and Hong Kong before becoming global director of strategy for the company. About 21 years ago, he decided constant traveling wasn’t good for his family with a newborn baby and accepted a role at what was then called Medical Care Corp.

“I joined before we had a product or a sales plan,” Fortier recalled.

At that time, tests for Alzheimer’s weren’t sensitive and scans like MRI would show the disease after it already took hold. There were also 90-minute cognitive batteries that were extremely complex, Fortier said.

“You needed a Ph.D. in neuropsychology to interpret them,” Fortier said.

Alzheimer’s is an illness that costs an estimated $345 billion annually, according to a report by the Alzheimer’s Association. Since the mid-1990s, the pharmaceutical industry has spent $42.5 billion on Alzheimer’s clinical trials; conservative cost estimates of Eisai and Lilly’s recent trials are $3 billion apiece, according to the Journal of the Alzheimer’s Association.

“We all change after the age of 40,” Fortier said. “The great difficulty is to know if the little things you’re noticing are due to aging, or you have a medical condition affecting your memory.”

Shankle and Hara invented Embic’s Mild Cognitive Impairment (MCI) technology through rigorous mathematical evaluation of widely adopted neuropsychological tests. During the 10-minute tests, a patient is read a list of 10 common nouns, asked to recall them immediately, and then asked again after a few minutes delay.

If impaired, the diagnosis may reveal something besides Alzheimer’s such as poorly controlled chronic conditions, thyroid dysfunction, stroke or depression.

“The Alzheimer’s field has a strong history of intervening too late. There is now treatment for Alzheimer’s disease, but you have to find it early.”

Cognitive Insights

Embic’s test, which is useful for insurance purposes, is eligible for Medicare reimbursement. The company has opened direct sales in the clinical channel and established distribution in 200 physician offices covering every Medicare region. It’s expanded distribution to Japan to participate in a 10-year demonstration project for the Japanese government, which is its largest customer.

The technology delivers “unprecedented insight into cognitive health” so company executives are considering commercial opportunities in areas like cognitive wellness traumatic brain injuries and other neuro-degenerative diseases, Fortier said.

Biogen is so upbeat about Leqembi that on Jan. 31 it announced it would drop its prior Alzheimer’s drug Aduhelm, a medication which had come under scrutiny regarding safety and efficacy issues.

“Patients are streaming into doctors’ offices for Embic’s tests,” Fortier said. “Once Leqembi won approval, demand for early detection exploded. People from the community are calling our office to be tested and we’ve never tried to sell to the public.”

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