Renalytix AI gets clinical laboratory permit in New York state

Artificial intelligence (AI) in vitro diagnostics company Renalytix AI has received a clinical laboratory permit from the New York State Department of Health (NYS DOH) to provide commercial testing of its ‘KidneyIntelX’ product.

The AIM-traded firm said 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 completed an inspection of the RenalytixAI New York laboratory as part of the process, with no findings reported.

Renalytix AI said it was now moving to complete full KidneyIntelX commercial integration with Mount Sinai Health System, with patient testing to begin in the third quarter.

With licensed CLIA commercial laboratories in Utah and New York, it said it could now provide KidneyIntelX testing services in 47 states, with expected licencing for California, Maryland and Pennsylvania in 2020.

“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,” the board said in its statement.

“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.”

Renalytix AI explained that a progressive decline in kidney function occurred when one or more conditions were observed.

As it announced on 10 June, a recent expanded multicentre validation study demonstrated that KidneyIntelX could 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.”

At 1216 BST, shares in Renalytix AI were up 4.82% at 471.7p.