1,112 Patient Study Demonstrates Clinical Utility and Care Benefits of KidneyIntelX™ Risk Stratification in Stage 1 to 3 Diabetic Kidney Disease Patients
June 10, 2022Late-breaking data presented at American Diabetes Association Scientific Sessions® demonstrates increased adherence to care guidelines for physicians using KidneyIntelX risk assessment to improve outcomes, alleviate patient suffering, and reduce significant financial burden associated with rapidly progressing chronic kidney disease.
Deployment of Renalytix’s (NASDAQ: RNLX) (LSE: RENX) KidneyIntelXTM bioprognosticTM testing in 1,112 adult diabetic kidney disease (DKD) patients at Mount Sinai Health System demonstrated utility in driving guideline appropriate use of therapies, including SGLT-2 inhibitors and RAAS inhibitor use, and timely consultation to specialists in high-risk patients. The Mount Sinai clinical utility data was presented as a late-breaking ePoster session on June 5th at the American Diabetes Association 82nd Scientific Sessions® in New Orleans. In the study, more than half of KidneyIntelX prognostic tests were ordered by primary care physicians, followed by endocrinologists. Application of guideline-based care, including therapeutics and appropriate specialist consultation, increased in proportion to reported risk of rapid progressive decline in kidney function (e.g., low, intermediate, or high risk).
“Before KidneyIntelX, we did not have a way to effectively predict which patients with early stage DKD are at higher risk for progressive loss of kidney function and kidney failure,” said Joji Tokita, M.D., Clinical Director, Division of Nephrology, and Associate Professor, Medicine (Nephrology), Icahn School of Medicine at Mount Sinai. “Nearly 95 percent of patients with chronic kidney disease are in stages 1 through 3, but its progression is often asymptomatic until it progresses to end stages and the damage is often irreversible. End-stage kidney disease results not only in poor quality of life for patients, but significant and costly care that can include cardiovascular complications, increased hospitalizations, dialysis and transplant. I’m encouraged to see the real-world application of KidneyIntelX by my primary care colleagues, where we can follow guideline-based care to reduce patient risk early and change the trajectory of disease progression and costs.”
“Understanding the clinical utility of diagnostic tools like KidneyIntelX in a real-world setting is critical to increasing access and availability of our testing in the United States,” said Tom McLain, President, Renalytix. “The findings from this clinical utility study reinforce the growing body of evidence demonstrating that KidneyIntelX can help to address significant unmet needs in DKD. An easy to understand, actionable risk score and care path allows primary care physicians to act early before health declines and significant kidney damage can occur.”
The breakdown of risk in the real-world evidence (RWE) population was similar to what was observed in peer-reviewed, published KidneyIntelX clinical validation cohorts: High risk 13% vs. 17%; intermediate 40% vs. 37%; and low risk 46% vs 46%. In the 1,112 patients tested, KidneyIntelX re-stratified patient’s risk from standard kidney function metrics (eGFR and UACR) and identified high risk adult patients with type 2 diabetes that were in stages 1, 2, and 3 of chronic kidney disease (CKD). Most importantly, the KidneyIntelX test helped physicians overcome the inertia seen with novel therapeutics proven to slow CKD progression and reduce associated patient cardiovascular event risk. As compared to patients who scored low risk, there were increases in use of anti-hypertensives, a 6-fold increase in the initiation of guideline-recommended treatments (SGLT-2 inhibitors or GLP-1 receptor agonists), and a nearly 3-fold increase in referrals to nephrologists, endocrinologists or dietitians. In the high-risk patient category, 20% of patients were referred to a specialist. Additionally, there was an increase in appropriate use of SGLT-2 inhibitor prescriptions by increased level of risk score.
“Even in my diabetes patients that are vigilant with their care, KidneyIntelX has proven to be a valuable tool to understand their risk of rapid kidney disease progression and take early action,” said Aida Vega, M.D., Associate Professor of Medicine (General Internal Medicine), Icahn Mount Sinai, and Director, Primary Care Program, Mount Sinai Doctors Faculty Practice. “Informed decision making and individualized care for CKD patients is vital in preventing associated complications and progression to end stage renal disease. The earlier we can understand the risk of rapid progression of the disease, the sooner we can take action to improve and preserve health for these patients.”
There are approximately 71,000 patients with type 2 diabetes and chronic kidney disease in the Mount Sinai Health System across New York City. Clinical utility study results are being prepared to be published in a peer reviewed publication in 2022. The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region.
KidneyIntelX is available clinically as a laboratory developed test. It has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and has been submitted to the FDA for De Novo marketing authorization.
KidneyIntelX includes technology that was initially developed by Mount Sinai faculty. This technology has been licensed by Mount Sinai to Renalytix. Mount Sinai and a small number of Mount Sinai faculty inventors have a financial interest in Renalytix. Mount Sinai also has representation on the Renalytix Board of Directors.
About Kidney Disease
Kidney disease is a public health epidemic affecting over 850 million people globally.1 The Centers for Disease Control and Prevention estimates that 15% of U.S. adults, or over 37 million people2, have chronic kidney disease (CKD). Nearly 95% of people with CKD are in early stages 1-33. Despite its magnitude, early-stage (1-3) CKD is underdiagnosed and undertreated, largely because it’s asymptomatic at this time in the disease. As many as 9 in 10 adults with CKD, and 2 in 5 adults with severe CKD do not know they have the condition.2
About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) is an in-vitro diagnostics and laboratory services company that is the global founder and leader in the new field of bioprognosisTM for kidney health. The leadership team, with a combined 200+ years of healthcare and in-vitro diagnostic experience, has designed its KidneyIntelX laboratory-developed test to enable risk assessment for rapid progressive decline in kidney function in adult patients with T2D with early CKD stages 1-3 . We believe that by understanding how disease will progress, patients and providers can take action early to improve outcomes and reduce overall health system costs. For more information, visit www.renalytix.com.
About KidneyIntelXTM
KidneyIntelXTM is a laboratory-developed test demonstrated to be a reliable, bioprognosticTM methodology that yields a simple-to-understand, custom risk score, enabling prediction of which adult patients with T2D and early CKD (stages 1-3) are at low, intermediate or high risk for rapid progressive decline in kidney function. By combining information from KidneyIntelX with newer cardio- and reno-protective therapies, doctors will have more information in determining which patients are at higher versus lower risk for rapid disease progression and may be able to more appropriately target resources and guideline-recommended treatments to advance kidney health. KidneyIntelX is supported by a growing body of clinical, utility and health economic studies (including a validation study of two large cohorts) and has a demonstrated a 72% improvement in predicting those patients who are at high risk for rapid progressive decline in kidney function versus the current standard of care (eGFR and UACR). KidneyIntelX has also received Breakthrough Device Designation from the U.S. Food and Drug Administration and has submitted for De Novo marketing authorization. To learn more about KidneyIntelX and review the evidence, visit www.kidneyintelx.com.
Sources
1 https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/
2 https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html
3 https://www.cdc.gov/kidneydisease/basics.html