Mount Sinai clinical utility data
![](https://tracker.prod.prod.rnssubmit.com/track.live-rns/4399454_6b796387bafb461f41df962c3713dcaf.png)
("Renalytix" or the "Company")
1,112 Patient Study Demonstrates Clinical Utility and Care Benefits of KidneyIntelXTM Risk Stratification
in Stage 1 to 3 Diabetic Kidney Disease Patients
Late-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
"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
"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 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
There are approximately 71,000 patients with type 2 diabetes and chronic kidney disease in the
KidneyIntelX is available clinically as a laboratory developed test. It has received Breakthrough Device Designation from the
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
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
About the
The
Sources
1https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/
2https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html
3https://www.cdc.gov/kidneydisease/basics.html
For further information, please contact:
|
||||
|
Via Walbrook PR |
|||
|
|
|||
Stifel (Nominated Adviser, Joint Broker) |
Tel: 020 7710 7600 |
|||
|
|
|||
|
|
|||
|
Tel: 020 7597 4000 |
|||
|
|
|||
|
|
|||
|
Tel: 020 7933 8780 or renalytix@walbrookpr.com |
|||
|
Mob: 07980 541 893 / 07584 391 303 / 07407 804 654 |
|||
|
|
|||
|
|
|||
|
Tel: 415-389-6400 or investors@renalytix.com |
|||
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential benefits, including economic savings, of KidneyIntelX, the potential for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, our expectations regarding reimbursement decisions and the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes. Words such as "anticipates," "believes," "estimates," "expects," "intends," "plans," "seeks," and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have only recently commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the