www.fdanews.com/articles/191213-fda-issues-breakthrough-designation-for-kidney-disease-test
![FDA_Logo_Black_2016.gif](https://www.fdanews.com/ext/resources/test/Drug-Images4/FDA_Logo_Black_2016.gif?t=1579040596&width=430)
FDA Issues Breakthrough Designation for Kidney Disease Test
May 7, 2019
Clinical test developer Renalytix received a breakthrough device designation from the FDA for its lead diagnostic KidneyIntelX.
The AI-enabled kidney disease diagnostic, the first of its kind, identifies patients with Type II diabetes with fast-progressing kidney disease.
The diagnostic uses machine-learning algorithms to evaluate predictive blood-based biomarkers, as well as a patient’s electronic health records, to detect progressive kidney disease.