JPM 2022: Renalytix plots de novo FDA nod for kidney disease AI, expands into drug response monitoring

KidneyIntelX uses machine learning algorithms to assess blood-based biomarkers and electronic health record data to diagnose fast-progressing kidney disease and can also be used over time to monitor patient responses to treatments for diabetes and chronic kidney disease. (jlcampbell104/CC BY 2.0)

After spending the past few years laying the groundwork for a full-scale launch of its KidneyIntelX technology, Renalytix is predicting that “2022 is going to be a heavy year of milestones,” CEO James McCullough said during a presentation at the J.P. Morgan Healthcare Conference Wednesday.

KidneyIntelX is an artificial-intelligence-powered tool that uses machine learning algorithms to analyze a trio of blood-based biomarkers and seven data points pulled from electronic health records. The resulting report gives a broad overview of a patient’s kidney health, generating a score of their individual risk of kidney disease progression or kidney failure.

So far, the platform has primarily been used to diagnose fast-progressing kidney disease in patients with Type 2 diabetes. In a study published earlier this week, however, it also showed promise in monitoring their response to various treatments for diabetic kidney disease.

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In addition to bringing its technology to at least 20 new health system partners, securing reimbursement from both Medicare and private insurers and forging strategic alliances with pharmaceutical and medical device manufacturers, the final milestone McCullough said Renalytix is “marching toward” this year is FDA clearance for KidneyIntelX.

The expected de novo marketing authorization would arrive as the culmination of about two years in regulatory purgatory, after Renalytix submitted the AI tool for FDA review in August 2020. That followed the agency’s move in May 2019 to grant its breakthrough-device designation—which expedites and smooths out the regulatory review process—to the technology, making it the first AI-enabled kidney disease diagnostic to receive the label, the company said at the time.

McCullough attributed the slow clearance process to backups at the FDA.

“We know they’re working hard down there, and they’re overwhelmed. I sympathize with them, but we are making progress there, and we expect to have that in 2022,” he said.

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McCullough’s presentation came a day after the treatment response study was published in the American Journal of Nephrology. In it, the risk scores generated by KidneyIntelX were found to change in correlation with the progression of diabetic kidney disease and with the introduction of novel treatments, indicating it could be a helpful tool in matching patients to the most effective treatment as early as possible.

The results were especially interesting to Renalytix, McCullough said, “because there are a whole sequence of new drugs which are entering the market, and we’re very much interested in looking at drug response and monitoring of therapeutic response and how it affects kidney response in these populations.”

Buoyed by the promising study findings, the company will next set its sights on further expanding the abilities of its AI platform, making it available not only for more clinical uses but also to assess more subtypes of chronic kidney disease and associated conditions, including cardiovascular disease, McCullough said.