Entries Published On October, 2017
According to the latest research, one in six Americans takes a psychiatric drug. Of those prescribed, the overwhelming majority belongs to the category of antidepressants. Sadly, when it comes to the standard of care for an antidepressant prescription, finding the right drug and the right dose is largely a trial-and-error process.
CNSDose recognizes that this method is complicated, it leads to unwanted side effects, and at best it’s only accurate in about 50 percent of cases. Due to the reduced cost of genetic testing, CNSDose has been able to personalize the treatment using advanced genetic testing of patient DNA. Now, with just a cheek swab, CNSDose can offer a suggested medication and dose after just five days.
We recently had the opportunity to speak with Harris Eyre, Chief Medical Officer of CNSDose. He gave us some insight into the problem, how the company is dealing with it, and what’s coming next.
Why Did CNSDose Choose Depression?
Eyre tells us that, first and foremost, the company is mission-driven. It’s not the typical medtech entity. “We’ve seen it clinically, know the devastation of the trial-and-error method on our patients, have delved into it scientifically, or we’ve been impacted by it personally.”
The technology was invented by a renowned psychiatrist and geneticist, Ajeet Singh MD Ph.D., who had taken it upon himself to understand why the trial-and-error method is done, and how it can be fixed. Eyre then came on board to support the commercialization through his commercial physician-executive skillset. He had seen the clinical issues that trial and error created, and the opportunities of genomics, so the mission of finding a better method which was highly scalable spoke to him.
Andrew Robb, the company’s Chairman, is a former Trade Minister in the company’s native country of Australia. He has written about his struggles with depression in his memoir, Black Dog Daze (Melbourne University Press). In his book, he tells of the story where he was targeted to become the leader of the opposition party in Australia but ended up having to take six months off from the job while dealing with the effects of the trial-and-error method of antidepressant dosing.
Beyond the personal nature of the mission, Eyre stresses that the field is also one of the fastest-growing diagnostic sectors in the history of medicine. The first-mover in the sector was acquired in 2016 in a $400 million exit, so there’s no question that the area is a hotbed of activity.
CNSDose has a significant amount of ammunition at its disposal. The company has a proprietary algorithm and a patent position around the blood-brain barrier genetics. But beyond that, it also has “the strongest support of any technology like this in the world” due to its clinical trial portfolio.
A randomized, controlled trial published in 2015 held the first positive results that the field had seen, and CNSDose was named as the most favorable technology in the market. “Over a twelve-week period, we could double the rate of recovery with CNSDose versus the trial-and-error method,” says Eyre.
Fast forward a year and the Department of Veterans Affairs released its own study showing that CNSDose had the most favorable findings in the field. Then, in 2017, a study was published showing that the CNSDose technology had an 89 percent accuracy at predicting the required dose the first time.
Overcoming the Obstacles
As with any young company, CNSDose has had to wrestle its way to where they are today. They have recently announced a contract with, and begun integration into, Intermountain Healthcare. As one of the largest private healthcare companies in the United States, servicing over four million customers, it’s a “huge deal for us as a seed-funded company.”
The other big part of the CNSDose story was coming to the United States and joining the Texas Medical Center’s digital health accelerator TMCx.
It was pretty amazing to be based at the largest medical center in the world. You have eminent researchers and clinics at your disposal, and this enabled us to get contracts signed or started while at TMCx. It was a great opportunity for us to test our business plan, our pricing model, for finding investors and directors and generally enriching ourselves in the US market.
Coming to America
We spoke at length about the choice to start in the United States. While the company originated out of Melbourne, Australia, the team quickly realized that the US was the best place for them to be. People in the United States, according to Eyre, are more open-minded to the technology. That said, the move did come with some challenges.
We realized that the US system is complex and fragmented, and we had enough sense to understand that we needed to get a US-based CEO.
With that knowledge in hand, the team engaged Mark Heinemeyer. Heinemeyer brings a wealth of experience to the team, having served in high-level positions at startups and growth-stage companies, as well as larger entities such as HCA, Cigna, and Fiserv. According to Eyre, “as a foreign company, we needed to tool ourselves into the US market with a senior healthcare executive like Mark.”
Regulation, The FDA, and the Australian Market
The great news for CNSDose and its customers is that there is not a specifically-required FDA approval for their product. Since it was produced as a lab-developed test, in an FDA- and CLIA-approved facility, CNSDose avoided the level of regulatory burden that we often see in the healthcare market.
That same burden was a big part of the reason why CNSDose landed in the US as its first market. While there are similar regulatory hurdles between the United States and Australia, Eyre tells us that things are “a bit more burdensome in Australia” as there is a need to submit a technical dossier for the product. CNSDose is completing the regulatory process in Australia and plans to ‘go live’ in February of 2018.
Costs and Benefits
While there are obvious benefits to both the patient and the provider in finding the right antidepressant dose quickly, there are other positives as well. So far, Eyre tells me, there is reasonable insurer coverage for the procedure, but even cash patients are able to afford the $399 price tag. Beyond that, however, economic models have forecasted savings in excess of $2,400 per patient, per year, in direct healthcare costs over trial-and-error prescription methods.
The Future of CNSDose
Eyre explains that, in three to five years, the company intends to find an exit through a strategic acquisition. In the interim, however, the team refuses to rest. While the team is staying laser-focused on depression right now, they are in the eminent stages of product development that will bring their genetic guidance systems to other areas of psychiatric medication such as ADHD, mood stabilizers, and antipsychotics.
“In three years it would be great to have our depression technology penetrated into the US market, and to have our pipeline of these other genetic guidance systems into the market and being offered.”
The team is also planning a move into a secondary market, with their home of Australia as the target within the next three years.