NEW YORK: Renalytix AI plc, an artificial intelligence-enabled in vitro diagnostics company, has received a clinical laboratory permit from the New York State Department of Health (NYS DOH) to provide commercial testing of KidneyIntelX.
The permit was granted following an extensive review by a panel of NYS DOH scientists and external reviewers of the analytical and clinical validation results for KidneyIntelX. Additionally, officials from the NYS DOH successfully completed an inspection of the RenalytixAI New York laboratory as part of this process, with no findings reported.
Effective immediately, KidneyIntelX may 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. With this approval, RenalytixAI will move to complete its full commercial launch of KidneyIntelX with Mount Sinai Health System and expects to begin reporting patient results in the third quarter of this calendar year.
KidneyIntelX is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment of progressive kidney function decline within a period up to five years. A progressive decline in kidney function occurs when one or more of the following conditions are observed:
- Rapid Kidney Function Decline (RKFD) in eGFR slope of ≥ 5 ml/min/1.73m2/year;
- a sustained decrease in eGFR ≥ 40% confirmed at least 3 months apart; or
- kidney failure, defined by sustained eGFR < 15 ml/min/1.73m2, initiation of long-term dialysis or kidney transplantation.
As announced on 10 June, a recent expanded multi-centre validation study demonstrated that KidneyIntelX can identify patients at the highest risk of progressive decline in kidney function in early stage diabetic kidney disease with higher accuracy than existing care methods.
The New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) regulates and oversees clinical diagnostic laboratories that test biological specimens from New York State residents. The CLEP seeks to ensure the accuracy and reliability of test results in clinical laboratories located within the state or that accept specimens from New York State residents.
While approval for KidneyIntelX patient testing has been granted for an indefinite period, it is subject to ongoing compliance with New York Department of Health regulations and standards. NYS DOH reserves the right to request more information and to withdraw the approval should evidence of non-compliance be identified.