Louisville-based physician team developed an early, simple and accurate test for chronic kidney disease, which is a silent killer affecting one in seven people and more than 850 million people worldwide. Their company, PrognostX Health, addresses the unmet clinical need in diagnosing patients early, before the disease becomes irreversible and untreatable.
Although the emphasis is on chronic kidney disease, PrognostX Health also provides innovative tests for early identification and treatment of other chronic diseases, according to Dr. Stephen Carrithers, Ph.D., who co-founded the company with his sons, Dr. Aaron Carrithers, MD and Dr. Brennan Carrithers, MD, MBA, MSc.
The company intends to bridge the gap between diagnosis and early treatment, he said.
Dr. Stephen Carrithers, PrognostX Health’s President and CEO, co-founded the venture after a lifetime of biotechnology innovation and commercialization, including the development of bench-to-bedside discoveries through the feasibility, R&D, validation, clinical, regulatory and licensing stages. He received his Ph.D. in biochemistry and molecular biology from the University of Louisville School of Medicine and fellowship in clinical pharmacology at Thomas Jefferson University Medical School, where he co-founded his first biotechnology company. His work as an academician prior to running his own biotech companies helped develop a unique skillset in business and science, which lent to his ability to evaluate, develop and identify clinical utility of healthcare innovation. In the past 25 years, he has developed a global network of collaborations and relationships that will help bring promising, yet underdeveloped technologies to the clinic through a patient-centric, personalized health focus on chronic disease.
Dr. Aaron Carrithers is a physician-scientist and clinical translational entrepreneur who has leveraged his expertise and experience to evaluate, develop and commercialize clinical diagnostics, especially in the clinical design and strategy, identifying utility to address the patient’s and doctor’s needs, regulatory, IP protection and clinical adoption strategies. He graduated from the University of Kentucky College of Medicine in 2018, followed by a postdoctoral fellowship in translational medicine and biotechnology while undergoing training from the Larta Institute, a biotechnology accelerator program that trains and assists startup founders to translate their R&D into commercially viable enterprises in healthcare. He served as director of clinical operations and principal investigator in two different biotech companies prior to co-founding PrognostX Health, where he now serves as VP and chief medical officer.
Dr. Brennan Carrithers, currently serving as the company’s health insurance implementation and reimbursement strategist, as well as on the clinical advisory and commercialization boards leveraging his expertise in high-volume data driven biomarker discovery, joined the team while completing his MBA during the last year of medical school in 2022. His expertise in population heath, healthcare analytics and insurance reimbursement strategies fills a niche the team needed while completing it validation studies in 2021-2022.
Kidney disease is currently recognized as a global epidemic affecting nearly 850 million people worldwide, and approximately 700 million of these patients have chronic kidney disease. Many are undiagnosed, untreated and unaware of their irreversible condition. In fact, 90% of people who actually have chronic kidney disease do not know they have it due to the subtle nature of progression. Furthermore, the current testing methods for chronic kidney disease takes at least three months, sometime up to a year, of repeat testing to actually determine if one has the disease. Unfortunately, nearly 60% of patients never return for follow-up appointments. As such, chronic kidney disease is associated with significant patient morbidity and mortality, including life-long dialysis, placing a huge financial burden on already struggling healthcare systems.
With a novel “diagnostics development” platform, PrognostX Health has leveraged more than 200 combined years of experience in diagnostics, clinical, regulatory, reimbursement, management, IP and commercialization, along with over $10 million in grants, to develop and validate its diagnostic test for chronic kidney disease that will be used to accurately and rapidly screen and monitor high-risk patients – i.e., those with diabetes and hypertension – and address the rising incidence and healthcare costs of end-stage renal disease and dialysis.
New medications to slow the progression of chronic kidney disease are available (as of 2021), and other medications are in Phase III clinical trials or currently being evaluated by the FDA. The problem is still an early and accurate diagnosis so patients can actually get treated sooner before late-stage complications arise. A one-time, single-assessment test for patients would be best for the high-risk population, and that is exactly what PrognostX Health has done.
PrognostX Health’s commercialization strategy has the potential to provide quick access to more than 75 percent of the U.S. market for its tests and accelerate clinical adoption. The technology will confirm chronic kidney disease and potentially identify patients who might best respond to the new medications that target disease progression. Customers for this simple, one-time diagnostic test include patients, doctors’ offices, clinics, hospitals, diagnostic reference and other diagnostic-related enterprises. The company is also planning to make this test available via direct to consumer.