Dive Brief:
- Renalytix AI has received FDA’s breakthrough device designation for an artificial intelligence-enabled clinical diagnostic tool to identify patients at risk for kidney disease progression and dialysis.
- KidneyIntelX uses machine learning algorithms to assess blood-based biomarkers, including sTNFR1, sTNFR2 and KIM1, in combination with electronic health record information, to identify progressive kidney disease.
- The technology is being developed in collaboration with the Mount Sinai Health System.
Dive Insight:
The International Society of Nephrology estimates more than 850 million people worldwide have some form of kidney disease yet most are not aware of having impaired kidney function. KidneyIntelX is intended to improve identification and treatment of Type II diabetes patients who have fast-progressing kidney disease.
Mount Sinai and the company in May 2018 announced a multi-year license and collaboration agreement for product development and commercialization of an advanced learning system to flag and monitor at-risk patients. The partnership gives Renalytix access to the health system’s data warehouse with more than 3 million patient health records plus 43,000 patient records in the BioMe biobank repository.
The technology platform is intended to draw from a combination of patient electronic health records, predictive blood-based biomarkers and other genomic information for analysis by learning computer algorithms, according to the company. The aim is to build a deep pool of kidney disease-related data for different AI-enabled applications to improve predictive capability and clinical utility over time.
In November, Renalytix secured $29 million in funding to support those efforts and started trading on the London Stock Exchange’s AIM market. Mount Sinai is a shareholder in the company and made an additional investment in the recent funding. RenalytixAI and Mount Sinai have said they expect to pursue expanded clinical utility trials through collaborations with leading academic medical centers, pharmaceutical and patient advocacy organizations in the United States and Europe, which will be followed by submission of product applications for review by FDA.
Renalytix was spun out from British medtech company EKF Diagnostics last year.
