Renalytix shares surged on Tuesday after publishing a two-year real-world evidence for its FDA-approved KidneyintelX.dkd test, the largest study of its kind to date, in the peer-reviewed journal Diabetes, Obesity and Metabolism.
The study followed 2,470 patients with type 2 diabetes and early-stage chronic kidney disease across the Mount Sinai Health System and Wake Forest/Atrium Health. It’s the first kidney prognostic tool shown to shift disease trajectory over a full two years, rather than just changing what doctors do in the short term.
The results were cheered by the market, and shares were 20% higher at the time of writing.
In terms of key stats from the study, 29% of retested patients moved into a lower risk category. Use of SGLT2 inhibitors in high-risk patients climbed to 56% (70% at Mount Sinai), and combination SGLT2/GLP-1 therapy nearly tripled, from 12% to 32%.
Patients started on these drugs had almost double the odds of reducing their risk. High-risk patients at baseline were 10.4 times more likely to see significant kidney decline than low-risk ones, a level of risk that standard tests can’t match.
KidneyintelX.dkd remains the only FDA-approved, Medicare-reimbursed test of its kind, and this is now its third consecutive evidence milestone.
One wonders whether the current £8m market cap reflects the real work impact KidneyintelX.dkd may have in the future.
Dr David Lam, Co-Principal Investigator Endocrinologist at Mount Sinai Health System, said:”These two-year data provide the clearest real-world picture yet of what risk stratification can do when applied consistently at scale in two large health systems.
“What we see is that a structured, biomarker-guided approach to prescribing translates into targeted therapy decisions – higher-risk patients receiving more intensive treatment, and lower-risk patients largely spared unnecessary escalation. That is what precision medicine is supposed to look like in practice.”