Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced the publication of a clinical utility study in The American Journal of Managed Care confirming Primary Care Physicians (PCPs) understand the value of KidneyIntelX™ in determining appropriate guideline-recommended treatment decisions in their adult patients with type 2 diabetes (T2D) and early chronic kidney disease stages 1-3 (diabetic kidney disease). The study of 401 geographically diverse clinicians was conducted by Boston Healthcare Associates, a third party specialized in medical device evaluation, clinical development, and data management.
The published study complements recently published data from a real-world evidence clinical utility study of 1,112 adult DKD patients presented at the recent American Diabetes Association 82nd Scientific Sessions and the European Congress of Internal Medicine. These combined published results confirm the significant benefit of using KidneyIntelX in the Primary Care setting to direct care towards improving kidney health and reducing the significant financial burden associated with DKD.
“The study publication announced today is a key element of a comprehensive evidence development program,” said Tom McLain, President of Renalytix. “This program was designed to address the evidence requirements of payers, regulators, clinicians, and guideline setting bodies. The increasing volume of real-world evidence being generated from our health systems partnerships, presented at the ADA conference, confirms clinical utility, and indicates adoption of KidneyIntelX in the clinical setting.”
“We now have evidence that indicates that KidneyIntelX is not only clinically valued by PCPs but is also useful in aiding clinical decision making in the real-world setting, helping ensure that patients are on the right care path at the right time," said Michael J. Donovan, Ph.D., M.D., Chief Medical Officer of Renalytix. “The adoption rate among PCPs as reported at the 2022 ADA late-breaking poster session on our real-world evidence study and the published clinical utility study underscores both the clinical need and clinician confidence in using KidneyIntelX to provide actionable risk stratification. In the real-world setting, this was associated with a 6-fold increase in the initiation of guideline-recommended treatments, and a nearly 3-fold increase in appropriate referrals.”
Results demonstrate growing awareness among PCPs in terms of the recognized value of KidneyIntelX in clinical decision making:
- The significance of these results was supported by a rigorous, analytical framework created to be highly representative of real-world care today and included 42 unique patient profiles and was designed to show what happens when KidneyIntelX is included vs. not included in patient care.
- The KidneyIntelX test had a greater relative importance than the standard of care (eGFR and UACR) for PCPs in prescribing guideline-recommended therapies and deciding when to consult with a specialist.
- 98% of PCPs responded they were somewhat, very, or extremely likely to use KidneyIntelX to predict which of their patients will experience rapid progressive kidney function decline.
- A behavioral shift among PCPs was examined after the introduction of KidneyIntelX. Approximately 80 percent of PCPs in the study noted risk assessment would support the decision to take more aggressive, guideline recommended clinical actions in high-risk, early stage (stage 1 through 3b) diabetic kidney disease patients.
“Adoption of KidneyIntelX among primary care physicians could play an important role in changing how we treat patients with diabetic kidney disease, by allowing for timely intervention in the early stages 1-3 of disease, when primary care physicians have the power to delay or prevent progression,” said Dr. Stephen Brunton, MD, FAAFP, CDCES, Primary Care Education Consortium, Family Practitioner and Executive Director of the Primary Care Metabolic Group. “This study adds to the growing body of clinical utility evidence showing how advanced prognosis tools like KidneyIntelX could help make more informed decisions in the management of patients, especially in early disease, and limit progression to end stage kidney disease.”
A total of 401 PCPs participated in the published clinical utility study. Respondents were recruited to ensure broad generalizability of results based on geographic and care model distribution, as well as a representative distribution of types of health insurance coverage. The geographic distribution of respondents was representative of the geographic distribution in the United States. The study was funded by a research grant from Renalytix.