Medicare prices kidneyintelX.dkd at $950

LONDON and SALT LAKE CITY - October 3, 2023 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX), the first company to commercialize an FDA approved artificial intelligence (AI) enabled prognostic blood test for individuals with type 2 diabetes and chronic kidney disease, announces that the Centers for Medicare & Medicaid Services ("CMS") has published the price for the Company's Food and Drug Administration ("FDA") authorized kidneyintelX.dkd test on the nationwide Clinical Laboratory Fee Schedule at $950.

The Company notes that earlier this year an American Medical Association (AMA) panel of experts recommended that the FDA authorized kidneyintelX.dkd test be assigned a new code to differentiate it from the original Laboratory Developed Test (KidneyIntelX). The recommendation by the AMA also required a national CMS (Medicare) pricing review that has now confirmed a published price on the national Clinical Laboratory Fee Schedule of $950.

When finalized in the fourth quarter of 2023, this pricing will be effective as of January 1, 2024 and maintained for a minimum of three years. The Company believes this CMS action, which has included both expert and public review and comment, affirms the value of the KidneyIntelX testing platform and importantly streamlines the pathway for maintaining and expanding health insurance coverage in the United States. The Company also believes it provides a strong pricing basis for international distribution agreements.

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Sources

2 https://www.cdc.gov/diabetes/basics/type2.html

3 https://www.cdc.gov/diabetes/data/statistics-report/index.html

4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/