Renalytix

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On Friday, Renalytix announced its collaboration with the world-renowned, innovation-leading Steno Diabetes Center Copenhagen. Its significance? The two visionary companies aim to increase awareness and provide more access to novel, precision medicine solutions for patients with type 2 diabetes and early-stage chronic kidney disease. Specifically, the collaboration will launch the first use of the Renalytix KidneyIntelX technology outside the U.S., showcasing the clinical utility of its AI-enabled, proprietary, biomarker-based blood test in the European Union. It will enable the early prognosis of CKD progression in type 2 diabetes patients, resulting in better-informed, precision-based care across a larger global footprint. This exciting news follows two recent announcements by the company. First, our FDA-approved kidneyintelX.dkd test was included in the international clinical guidelines for kidney care, KDIGO . Second, that the test received full coverage determination from Medicare. Check out the full press release here: https://lnkd.in/eTeGXAXc Fergus Fleming Steven Coca Girish Nadkarni Peter Rossing Frederik Persson PRIME-CKD Howard Doran Michael J. Donovan PhD, MD Tim Fitzpatrick #diabetes #ckd #biotech #diagnostics

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ICYMI: We've just reached another milestone on our commercialization journey, which should continue to drive positive test adoption. Yesterday, Medicare issued a final Local Coverage Determination (“LCD”) for our Company’s kidneyintelX.dkd test. What's the importance of such a distinction? It has been determined that kidneyintelX.dkd is both reasonable and necessary, and therefore, the LCD specifies coverage of our bioprognostic test, which is used to determine the level of risk for progression of kidney function decline in patients with diagnosed Type 2 diabetes and Stage 1-3b Chronic Kidney Disease. This news came on the heels of our test's inclusion in the international clinical guidelines for kidney care (KDIGO) and our FDA approval. This is yet another step toward achieving our mission of eradicating kidney disease one patient at a time.

We’re excited to announce that our KidneyIntelX in-vitro diagnostic test has been included in the final KDIGO 2024 Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease. By including our test in the Guidelines, the Guideline Work Group recognized that the progression of CKD can occur at all stages, and that in earlier stages of disease (G1–G3), understanding the risk of 40% decline in kidney function over a short term period of 5 years, as per the indicated use of KidneyIntelX, is important for guiding early intervention, particularly in people at intermediate or high risk for progression. Separately, but serving as additional support of the Work Group’s action to include the test, in January 2024, published outcomes data from an analysis of more than 2,500 patients with one year of follow-up demonstrated that providing clinicians access to KidneyIntelX risk assessment to inform care was associated with clinical actions that resulted in sustained reduction in eGFR decline, improved diabetes management and improved cardiovascular health.

When we say that “our singular goal is to eradicate kidney disease,” do you think it’s too much of a promise? We don’t. It seems to us that everyone in the healthcare ecosystem should be making the same promise. Because today, we’re all failing. Chronic kidney disease impacts 850 million patients worldwide and close to 37 million in the U.S. And a new NEJM study found that the rate of chronic kidney disease in the U.S. has markedly increased in recent years – and is estimated to continue to increase - along with rising rates of diabetes. We have 2 even bigger problems. 1. Kidney health is closely connected with CV and metabolic health, and there is greater risk for CV events among patients with type 2 diabetes and impaired kidney function. 2. Chronic kidney disease is a “silent killer.” It’s a disease that progresses slowly, typically without any symptoms in its early stages. With no pain to report, it’s often missed. So, we need to make significant changes…and fast. If we don’t, many more lives will be at risk for kidney failure, increasing the need for dialysis or transplantation. That’s why we wholeheartedly support World Kidney Day and National Kidney Month. But we believe in full on action every day of the year. Through our KidneyIntelX™ bioprognostic™ technology, we identify adult patients with T2D and CKD (stages 1-3b) who are at risk for progressive decline in kidney function. Accurately assessing patient-specific risk earlier enables clinicians to target resources, therapeutic options, and care plans more appropriately, thereby increasing the chance for slowing disease progression and improving patient outcomes. Let’s be the generation remembered for eradicating kidney disease. Steven Coca Girish Nadkarni Thomas McLain Howard Doran Fergus Fleming Michael J. Donovan PhD, MD

Can one simple blood test help slow progression of chronic kidney disease and improve type 2 diabetes control in just 12 months?   Yes it can. We just proved it (again, as we already proved it with our 6 month data).   Check out our just published Real World Evidence which features 12 months of follow-up data in 2,469 patients with type 2 diabetes and early-stage chronic kidney disease at a major health system. The published results demonstrate the effect seen at 6 months are maintained at 1 year, providing confidence that even a single KidneyIntelX risk assessment test can deliver durable benefits in terms of clinician and patient behavior and hard outcomes. We were able to demonstrate that our KidneyIntelX bioprognostic test resulted in improved adherence to guideline recommended care, including the use of SGLT2i and GLP1 RAs at 66% and 64% in high and intermediate risk patients post-testing, far exceeding national averages. The reported improvement in key cardio-metabolic health metrics also demonstrate the patient health benefits are beyond kidney disease. This includes: - a reduction in the rate of kidney function decline (eGFR slope), AND - improved A1C levels, AND - an increase in the percentage of KidneyIntelX high-risk patients who achieved blood pressure control   See data here: https://lnkd.in/e59rcWaB Holly Kramer Katherine Tuttle Steven Coca Girish Nadkarni Thomas McLain Fergus Fleming Michael J. Donovan PhD, MD

Alongside her colleagues, we are honored to celebrate Katherine Tuttle, MD, FASN, FACP, FNKF, Clinical Professor, Executive Director for Research at Providence, Regional Co-Principal Investigator for the Institute of Translational Health Sciences, and recent winner of the 2023 John P. Peters Award, which recognizes individuals who have made substantial research contributions to the discipline of nephrology and have sustained achievements in one or more domains of academic medicine including clinical care, education and leadership. Our paths have crossed multiple times, most recently, with two of our Renalytix Well Filtered blogs, where we discussed both advances in kidney research and the tenets for pushing kidney health forward. In her acceptance speech during American Society of Nephrology's Kidney Week, she said that her "calling was to address the enormous unmet need in treatments for patients with T2D and CKD." We share her calling and passion, and hope to contribute (even a fraction) of what she's accomplished in her decades of work in this area. Cheers to you, Katherine. And to the next ten years.

It's always a bit of a let-down when we're back from all of the excitement at ASN. We found the sessions thought-provoking and the discussions with nephrologists and other clinicians invigorating. We got to share Renalytix news, which included receiving FDA De Novo Marketing authorization for kidneyintelX.dkd and our still relatively new consortium partnership in Prime CKD, where together, we are striving to shape the future of precision medicine in CKD. Here's a pic of some of the Prime CKD crew, from left to right: Peter Rossing, Hiddo Jan L. Heerspink, Wenjun Ju, Sharon Stapleton (Renalytix), Viji Nair, Fergus Fleming (Renalytix), Michael J. Donovan PhD, MD (Renalytix), and Matthias Kretzler.