NEW YORK – Kidney disease diagnostics firm RenalytixAI announced Friday it has received a clinical laboratory permit from the New York State Department of Health allowing the company to provide its KidneyIntelX test to residents of the state.
The test can now be used to report risk assessment results for fast-progressing kidney disease and future kidney failure for patients with Type 2 diabetes and chronic kidney disease. KidneyIntelX is meant to be used with clinical evaluation to help in the risk assessment of progressive kidney function decline within five years.
A panel of DOH scientists and external reviewers conducted a review of the test's analytical and clinical validation results and NYSDOH officials inspected the firm's New York laboratory before granting the permit. The approval is effective immediately and has been granted for an indefinite period, but it is subject to compliance with state standards and can be withdrawn in the case of non-compliance.
The London-based artificial intelligence company said it will now move to complete KidneyIntelX's full commercial launch with Mount Sinai Health System and will likely start reporting patient results in the third quarter of 2020. A recent study found the test can identify patients at the highest risk of progressive decline in kidney function in early-stage diabetic kidney disease with higher accuracy than current methods.
In April, RenalytixAI partnered with Mount Sinai for a clinical study to analyze biomarkers to predict major adverse kidney events in patients hospitalized with COVID-19.