LONDON - Renalytix plc (NASDAQ: RNLX) (LSE: RENX), a company specializing in artificial intelligence-enabled in vitro diagnostics for kidney disease, has announced a collaboration with Steno Diabetes Center in Copenhagen. The partnership aims to integrate Renalytix's KidneyIntelX platform into the European clinical setting, marking its first application outside the United States.
The initial phase of the collaboration will focus on developing a roadmap for implementing KidneyIntelX at the Steno Diabetes Center and its affiliated practices. This will involve incorporating biomarker testing into laboratory workflows, educating clinicians and patients about the test's role in care management, and leveraging electronic health records for efficient, risk-based care.
Professor Peter Rossing, a senior investigator at Steno, highlighted the potential of KidneyIntelX to enhance patient care by ensuring that individuals receive the most appropriate treatment early in their disease. Dr. Frederik Persson, Head of Clinic at Steno, expressed the center's commitment to bridging the gap between novel technologies and clinical practice.
The collaboration also includes addressing regulatory requirements for CE marking in the EU, analyzing clinical utility data, and fostering clinical adoption in line with national and international guidelines.
Fergus Fleming, CTO of Renalytix, welcomed the partnership as a significant step in expanding access to precision medicine for kidney disease patients in Europe. The insights gained are expected to inform Renalytix's commercialization and product development strategies both in the US and internationally.
Renalytix and Steno are participants in the PRIME-CKD project, funded by the European Union, which focuses on advancing personalized drug treatment for chronic kidney disease (CKD).
The announcement is based on a press release statement and contains forward-looking statements. Renalytix's KidneyIntelX, recognized by the FDA as a prognostic test for early-stage CKD risk assessment in type 2 diabetes patients, is at the heart of this initiative.
The collaboration's outcomes will help define a framework for precision medicine implementation in Europe, potentially influencing future Renalytix product development for monitoring therapeutic responses in diabetic kidney disease.
In other recent news, Renalytix, an AI-enabled in-vitro diagnostics company, announced that its kidneyintelX.dkd testing has received final Local Coverage Determination (LCD) from Medicare. The test, priced at $950, will be available for patients with Type 2 diabetes and Stage 1-3b Chronic Kidney Disease starting August 1, 2024.
This Medicare coverage aligns with the U.S. Food and Drug Administration's label for the kidneyintelX.dkd test and comes after the establishment of distinct CPT codes for the test in the CMS' 2024 Clinical Lab Fee Schedule. National Government Services, a subsidiary of Elevance Health, Inc., will process the claims for the tests conducted in Renalytix's New York City laboratory.
The kidneyintelX.dkd test, recognized as the first and only FDA-authorized prognostic test for early-stage Chronic Kidney Disease risk assessment in patients with Type 2 diabetes, aims to enable earlier intervention to improve patient outcomes and reduce healthcare costs. CEO James McCullough expressed optimism that this development could encourage further major coverage decisions and expedite the adoption of the testing.
InvestingPro Insights
As Renalytix plc (NASDAQ: RNLX) (LSE: RENX) embarks on its European journey with the KidneyIntelX platform, investors are keeping a close eye on the financial health and market sentiment surrounding the company. In the last twelve months as of Q3 2024, Renalytix has faced challenges, reflected in a substantial 40.23% decline in revenue and a negative gross profit margin of -1.58%. The market capitalization, adjusted to 24.02M USD, further underscores the size of the company in comparison to its competitors.
InvestingPro Tips suggest caution, indicating that the stock is currently in oversold territory and highlighting the company's rapid cash burn. Analysts are also expecting a sales decline in the current year. Additionally, with short-term obligations exceeding liquid assets, Renalytix's financial stability may be of concern to potential investors. These insights are particularly relevant as Renalytix navigates the complex regulatory and commercial landscapes in Europe.
For investors seeking a deeper analysis, there are 12 additional InvestingPro Tips available, providing a comprehensive understanding of Renalytix's financial position and market performance. These tips can be accessed through the InvestingPro platform, and interested readers can use the coupon code PRONEWS24 to receive up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, offering valuable insights to inform investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.