Go ahead,

test us.

FACT 1

Not all early risk assessment “solutions” are the same, even though their claims may seem similar.

FACT 2

kidneyintelX.dkd™ is the first and only FDA authorized test to enable risk assessment for progressive kidney function decline in adult patients with type 2 diabetes and chronic kidney disease (stages 1-3b). Therefore, kidneyintelX.dkd sets a high bar as the predicate for same or like tests to be reviewed by the FDA in the future.

“If all we had to go on were values for eGFR and UACR, those might not have prompted us to do anything. But instead, we saw “high risk” or “moderate risk” through the KidneyIntelX technology, and it raised a red flag. We brought the patient back more quickly. Otherwise, they may have gone another 6 months or a year before any renal change was diagnosed.”

Dr Aida Vega
Associate Professor of Medicine
Director of the Mount Sinai Faculty Practice Associates Primary Care Program at Icahn School of Medicine at Mount Sinai in NY, NY

FACT 3

Only Renalytix founded this new bioprognostic™ methodology for kidney health via kidneyintelX.dkd, which starts with a patient blood test to identify biomarkers demonstrated to be highly prognostic for kidney disease progression and combines select clinical data features to generate an actionable result (Low, Moderate, or High).

FACT 4

kidneyintelX.dkd is implemented in stages 1-3b, when it matters most.

By starting in stages 1-3b of diagnosed kidney disease and implementing kidneyintelX.dkd – a test demonstrated to determine which adult patients with type 2 diabetes and early chronic kidney disease are at more vs. less risk for progressive decline in kidney function – clinicians and patients will reap the greatest benefits from their re-evaluated treatment plan.

FACT 5

The clinical validation study for kidneyintelX.dkd demonstrated an unadjusted HR for high vs low risk at 18-fold and 8-fold, respectively, when adjusted for age, sex, race, eGFR, UACR, A1C and BP.

FACT 6

kidneyintelX.dkd has obtained both a national payment rate from Medicare and final coverage determination.

As of January 2024, the Centers for Medicare and Medicaid Services (“CMS”) set a national price for our kidneyintelX.dkd test with a unique reimbursement code, 0407U. In June 2024, Medicare also set final coverage determination for the test.