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Company has Achieved Prerequisites for Growing Test Adoption with FDA Authorization, Clinical Outcomes Data, Inclusion in Clinical Guidelines, and Broad Insurance Coverage

LONDON and NEW YORK, June 14, 2024 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces that on June 13, 2024 Medicare issued a final Local Coverage Determination ("LCD") for the Company's kidneyintelX.dkd testing. The final LCD can be accessed at LCD - KidneyIntelX and KidneyIntelX.dkd Testing (L39726) (cms.gov), and is effective for dates of service on or after August 1, 2024. The established Medicare price for kidneyintelX.dkd is $950 per test. Distinct CPT Codes (Common Procedural Terminology Codes) have been established for kidneyintelX.dkd and is published in CMS' 2024 Clinical Lab Fee Schedule.

The LCD specifies coverage for use of kidneyintelX.dkd for patients with diagnosed Type 2 diabetes and Stage 1-3b Chronic Kidney Disease is reasonable and necessary. Any specified limitations for use conform to the U.S. Food and Drug Administration ("FDA") label for kidneyintelX.dkd. The LCD was issued by National Government Services ("NGS"). NGS is a subsidiary of Elevance Health, Inc. (previously Anthem, Inc.), a Medicare Administrative Contractor responsible for claims processing for testing performed in the Company's New York City laboratory.

“With final Medicare Coverage, an FDA authorization, and an April recommendation in the international clinical guidelines, kidneyintelX.dkd is poised to be a preventative medicine standard for 14 million people in the United States living with diabetes and kidney disease. We expect this Medicare coverage will prompt additional major coverage decisions and help accelerate testing adoption,” said James McCullough CEO of Renalytix. “We remain focused on incremental sales growth in targeted US regions with a now significantly lower cost of operations.”

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About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) is an artificial intelligence enabled in-vitro diagnostics and laboratory services company that is the global founder and leader in the field of bioprognosis™ for kidney health. In late 2023, our kidneyintelX.dkd test was recognized as the first and only FDA-authorized prognostic test to enable early-stage CKD (stages 1-3b) risk assessment for progressive decline in kidney function in T2D patients. By understanding how disease will progress, patients and clinicians can take action earlier to improve outcomes and reduce overall health system costs. For more information, visit www.renalytix.com.