NEW YORK — Renalytix said Thursday that it has partnered with the Steno Diabetes Center Copenhagen to plan the commercialization of the company's KidneyIntelX prognostic kidney disease test in Europe.
KidneyIntelX applies machine learning to three proprietary plasma biomarkers — soluble tumor necrosis factor receptors 1 and 2 and plasma kidney injury molecule-1 — and clinical data from electronic health records to generate a risk score for kidney disease.
The immunoassay, which has been available as a laboratory-developed test since 2020 and received US Food and Drug Administration clearance about a year ago, is intended for use in patients with type 2 diabetes and early-stage chronic kidney disease, stratifying them based on risk for rapid progressive kidney function decline within five years.
UK-based Renalytix, which has recently been ramping up US commercialization efforts for KidneyIntelX, said that it will work with Steno on the clinical translation of the test in European markets, focusing on integrating biomarker testing into laboratory workflows, educating clinicians and patients on the role of KidneyIntelX risk assessment, and using electronic health record systems for risk-based care management.
Renalytix and Steno will also examine the requirements for the test's CE marking in the European Union under the In Vitro Diagnostic Regulation, as well as necessary clinical utility data, cost effectiveness analyses, and clinical adoption in accordance with national and international clinical guidelines.
In addition to aiding in the commercialization of KidneyIntelX in the EU, the collaboration is expected to define requirements for future product development of tests by Renalytix to predict and monitor therapeutic response in diabetic and chronic kidney disease, Renalytix said.
"The insights gained from this collaboration will be pivotal in informing our commercialization and product development activities in the US and abroad," Renalytix Chief Technology Officer Fergus Fleming said in a statement.
Financial and other terms of the deal were not disclosed.