Approximately 88 million Americans have prediabetes. The vast majority of those individuals don't know they have it. With prediabetes, a person's blood sugar levels are higher than normal but not high enough for them to be diagnosed with type 2 diabetes. According to the Centers for Disease Control and Prevention, prediabetes not only increases your risk of developing type 2 diabetes but may cause other issues and aftereffects of this chronic disease include kidney, heart, or event Alzheimer’s disease.

While some individuals will live with prediabetes for the rest of their lives, a percentage of prediabetic patients progress quickly into type 2 diabetes and most likely develop other serious irreversible conditions.

"What's difficult about prediabetes is that 5 to 10 percent (of patients) will rapidly progress to type 2 diabetes and develop related conditions like chronic kidney disease, heart disease, dementia, or eye disease," explained Dr. Aaron Carrithers, the Chief Medical Officer and Vice President of AmDx PrognostX.

"Prediabetic patients have no way of knowing whether or not they exist in that 5 to 10 percent high-risk rapidly progressive subgroup or if their condition is among the 90 to 95 percent (of prediabetics) who are at a much lower risk of progression and could potentially go on living normally for the rest of their lives. That's why although there are medications approved for prediabetics, it is currently not recommended to treat any of them unless there is an indication that they might be at high risk for progressing faster or developing one of these chronic conditions. There are two very different prediabetic populations, and while the vast majority are low-risk and do not require early medical intervention, there is another subgroup (of prediabetics) that behaves pathologically different and suffers from significant irreversible ‘microvascular’ damage while still in the prediabetic state. This ‘high-risk’ subpopulation could drastically benefit from early treatment, which would help slow or even stop progression to diabetes."

But what if there was a simple test a patient could take to indicate whether or not they were likely to develop a serious condition?

Enter AmDx PrognostX, a company that is working to develop an immunoassay blood test—a test to identify the presence of a specific biomarker in a blood sample—for early diabetes-related microvascular dysfunction, a disease where the small blood vessels that deliver blood to the heart, kidney, brain, and eye don't work as they should. This type of microvascular disease causes some of the similar symptoms of other heart or kidney issues—chest pain, shortness of breath, diminished kidney function—but can be extremely difficult to diagnose. The goal of the AmDx test is to be able to identify patients who would have developed this underlying disease so that they can follow up with a physician to start proactive and preventative treatment. The AmDx test would essentially help identify and diagnose the prediabetic (or even the early stage type 2 diabetic) patient who would benefit for therapeutic intervention—medications that are already available to these patients but cannot be prescribed under standard of care unless a diagnosis can be made. The test would fulfill this unmet clinic need.

"There's no test to tell you what [chronic] disease you're going to get. So we found that this is our niche—we're going to be able to inform patients that they're going to progress faster than their neighbor who also has type 2 diabetes, yet they're not going to understand why they progress so much faster. We're going to be able to give them an answer. And now we can treat them. The medications are out there, but a doctor will not [and cannot under current standard of care guidelines] provide this to a patient until they know what the problem is going to be," explained Dr. Stephen Carrithers, founder and CEO of AmDx PrognostX.

For Dr. Stephen Carrithers, the newly created AmDx PrognostX comes after a lifetime of work in biotechnology. For the past 30 years, he's researched, explored, and developed various diagnostics, specifically looking at diseases in the colon and kidney, and has launched a handful of biotech startups that have received more than $12 million in non-dilutive funding. Most recently, he led a team in developing an early diagnostic test for chronic kidney disease through one of his previous ventures. This diagnostic test for chronic kidney disease is being developed and marketed as a laboratory developed test for clinicians, and is moving into FDA approved clinic trials. The studies have not only returned promising results so far but the test has been licensed by AmDx PrognostX to enhance its pipeline of clinic diagnostic products.

"It took us a little time to develop the (chronic kidney disease) diagnostic test but what we have found is that we have strategic partnerships and have developed a streamlined approach to develop diagnostics much faster for the market," Dr. Stephen Carrithers said.

Armed with experience and the strategic partnerships to bring the tests to market, he stepped up to the plate when the University of Kentucky asked him to work on creating a test for prediabetes, and AmDx PrognostX was born.

Of course, since he wanted to go fast and yet mitigate early in the development process any concerns over what the market (and clinic) would want, he couldn't go alone. He knew he needed a doctor of medicine (MD) helping guide the project. He didn't have to look far as his son Dr. Aaron Carrithers recently graduated from the University of Kentucky in 2018 with his MD and postdoc experience in translational medicine and biotechnology. The duo has also convinced Aaron's younger brother, Brennan Carrithers, MD, MBA, MSc., a current resident at New York University, to help out as well.

"What we find really unique about our team is the MBAs, the MDs, and the PhDs, are all in one family," Dr. Stephen Carrithers said. "I own my own laboratory, so I don't have to farm out a lot of work. We have our research facility—which I built a couple years ago. And when you own your own laboratory and office space, a lot of doors can be opened, creating an excellent research and clinical environment with freedom to operate and innovate."

For AmDx PrognostX, the family dynamic keeps ideas flowing.

"There's just an effortless flow that immediately resonates within the room or the meeting. There's no warming up," Dr. Aaron Carrithers explained. "Things seem to start happening much more easily when you have that level of trust, respect, and confidence in one another."

While the team says AmDx is currently operating in stealth mode since officially incorporating in 2020, their immediate goal is to develop an effective prediabetes test, that would predict which patient would progress into kidney disease, something that has required the team to spent a lot of effort in the lab. However, soon after the team negotiated the exclusive option for the license with the University of Kentucky in 2021, the company was awarded its first Small Business Innovation Research (SBIR) Phase I grant from the National Institutes of Health (NIH). These funds are currently being employed to continue testing proof of concept and feasibility of the diagnostic test product for the targeted clinical indication. Also, the Kentucky Cabinet for Economic Development recognized the need and value for such a test, especially in the state, and granted AmDx PrognostX an SBIR Matching Funds Award in early 2022. Thanks to this support, the team believes that their test can now be manufactured in an affordable fashion while at the same time remain accurate, sensitive, and specific.

The AmDx PrognostX team has also relied on the expertise of the individuals in the University of Kentucky Office of Commercialization (UK OTC) and the UAccel program to keep them moving forward. With the grant funds, personal investment, and coaching, the team is armed with not only the resources and data required for Phase II research and development grants, but they are ready to leverage UK OTC’s offerings to take the next steps in their commercialization plan—seeking investment to help expedite the sale of AmDx’s clinical diagnostic products.

In order to de-risk their commercialization activities, AmDx PrognostX has brought in a very successful and proven expert in clinical diagnostics, strategic and financing partners that expedite development of such, and licensing of diagnostic tests. Tien Bui, who has worked with the AmDx team since 2018, when Dr. Aaron Carrithers was selected to participate in the highly-accredited Larta commercialization assistance program through NIH. While they remained in touch periodically upon completion of the program in 2019, it wasn't until Drs. Carrithers and Carrithers called upon her guidance again, this time as the Chief Business Development and Strategic Partnerships Officer and Executive Board Member for AmDx PrognostX.

"With Tien's expertise and proven experience in developing, licensing, business development, and marketing in the clinical diagnostics space, we have added to our team a 'superstar' in the field and helped round out our business model as a whole,” Dr. Stephen Carrithers said. “She not only has worked in the Larta system for over 14 years, but she has negotiated strategic partnerships with Pfizer and other very large biopharmaceutical companies and was the primary business lead when she licensed her company's clinical diagnostic tests to LabCorp for approximately $119 million. Her deep functional expertise in sales, marketing, and medical affairs round out a team at AmDx PrognostX that is second to none in taking a diagnostic test from bench-to-bedside. Lastly, she has known us for a long time and works well within the company's culture, which is very important for success in the biotechnology space."

AmDx PrognostX has also been working through the University of Kentucky's Entrepreneurship in Residence program, where they were selected by Russ Donda, a proven and seasoned CEO, to move the company forward to be ready for investment and commercialization.

Now doing business under the banner of "PrognostX HEALTH", the company is preparing to seek investment and open a round soon. The team feels that they are now poised for success, having recently been awarded an SBIR Phase II from the NIH of more than $2 million.

"Strategic partnerships that will help commercialize our IP and products as well as acquiring ‘smart money’ in regards to capital raises will be important in the next 12 months for the company,” Dr. Stephen Carrithers said. “Our MVP and laboratory developed tests can be on the market during this SBIR Phase II award [within the next 12-18 months], but we understand that the tasks required to be in the marketplace in multiple formats to address multiple clinical indications require activities performed in parallel, not tasks performed sequentially. We have the plan to implement these actions with all the pieces coming together very nicely. Our tests for kidney disease are more than 95 percent accurate and will most certainly help address the rising incidence and costs of diabetes, dialysis, and end-stage renal disease.

“We have some great technologies and we have a realistic and extremely high-reward business plan on the backside of it. But at the end of the day, it's about the patient. Our goal is always being able to help the patient, and I think we have the tests that are going to be the difference maker.”

By: Erin Shea

Launch Blue nurtures promising startup founders and university innovators through intensive accelerator and incubator programs. Its funding partners are the University of Kentucky: Office of Technology Commercialization, KY Innovation, the U.S. Economic Development Administration, and the National Science Foundation.