Renalytix AI begins clinical validation study for 'KidneyIntelX'

The AIM-traded firm said KidneyIntelX was designed to diagnose and improve clinical management of patients with type 2 diabetes, and those of African ancestry with fast-progressing kidney disease, in an effort to curtail the estimated $114bn cost of chronic and end-stage kidney disease to the United States healthcare system.

As outlined at the time of its initial public offering, Renalytix AI said it expected to commercially launch KidneyIntelX as a laboratory-developed test in its CLIA laboratory facilities to health systems and drug developers in the second half of 2019.

The expanded validation study programme now included investigators from Johns Hopkins Medicine, Emory University, the Icahn School of Medicine at Mount Sinai, Northwestern University, Harvard University and Brigham and Women's Hospital.

Renalytix said KidneyIntelX would use machine learning algorithms to assess the combination of predictive blood-based biomarkers, including sTNFR1, sTNFR2, and KIM1, in combination with electronic health record information.

Identification of patients with chronic kidney disease (CKD) who were at risk of, or were experiencing, rapid kidney function decline, was described by the company as “challenging”.

However, it explained that the KidneyIntelX test would “significantly improve” the identification of those patients in the early stages of CKD, thereby improving care and outcomes for those patients through early initiation or escalation of treatment strategies.

“The expanded validation patient cohort increases the statistical power of KidneyIntelX and is expected to provide additional insight into the design of the planned clinical utility study,” the Renalytix AI board said in its statement.

“Data from the clinical validation study will also be used to support the submission of KidneyIntelX for US Food and Drug Administration review in 2019.”