US Government coverage expanded

LONDON and SALT LAKE CITY, February 29, 2024 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX) ("Renalytix" or the "Company") announces that effective March 1, 2024, the United States Government has approved adding the company's Food and Drug Administration ("FDA") de Novo Marketing authorized test, kidneyintelX.dkd, to its 10-year Governmentwide Acquisition Contract (GWAC) for early-stage kidney disease bioprognostic™ testing services. Pricing for kidneyintelX.dkd is set at $950 per reportable result. The contract, effective through 2031 and offered through the General Services Administration (GSA), covers laboratory testing services provided by any government healthcare facility, including the U.S. Veterans Administration (VA), Department of Defense (DoD) military branches (the Army, Marine Corps, Navy, Air Force, Space Force, and Coast Guard), and Indian Health Services (IHS).

In addition, today National Government Services ("NGS"), a Medicare Administrative Contractor (MAC), is holding its first quarter Open Public Meeting that includes consideration of its proposed coverage policy for KidneyIntelX and kidneyintelX.dkd testing. As disclosed previously, NGS has adopted a consistent payment approach for KidneyIntelX testing that is expected to continue through the finalization of the proposed coverage policy.

During the Open Public Meeting, both representatives from Renalytix and third-party external experts will speak in support of coverage policy DL39726 for KidneyIntelX and kidneyintelX.dkd testing. Speakers will include:

• Dr. Tahir Effendi, MD, FACP, Internal Medicine Specialist at Hudson Shores Medical Group;
• Dr. Barry Freedman, MD, John H. Felts, III Professor of Medicine and Chief, Section on Nephrology at the Wake Forest University School of Medicine; and
• Dr. Joji Tokita, MD, Nephrologist and Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai.

During the meeting, the presenters will share data to demonstrate the clinical value of KidneyIntelX from studies enrolling a combined 9,000 patients from the Mount Sinai Health System and the Atrium/Wake Forest Health System who are being treated based on their initial risk assessment result. An expanded presentation of key data has been accepted for the National Kidney Foundation (NKF) Spring Clinical Meeting being held May 14-18, 2024.

Following the Open Public Meeting, NGS will review and respond to letters submitted during an open comment period that ends on March 23, 2024. Renalytix expects issuance of a final Local Coverage Determination ("LCD") could occur during fiscal year 2024. If the LCD is finalized in its proposed form, Medicare (through NGS) will provide coverage for KidneyIntelX and kidneyintelX.dkd testing, provided that the terms of the LCD are met.

Effective January 1, 2024, KidneyIntelX and kidneyintelX.dkd testing has been priced at $950 on the Centers for Medicare and Medicaid Services (CMS) Clinical Lab Fee Schedule ("CLFS"). The CLFS is a complete listing of the approved fees Medicare will pay for individual laboratory tests. It is used to reimburse clinical laboratories like Renalytix for their testing services. Published pricing for Clinical Laboratory Diagnostic Tests like kidneyintelX.dkd are effective for three years.

Collectively, these advancements are expected to facilitate insurance reimbursement for 10 million of the 14 million patients in the United States that fall within the FDA Authorized indication for use of kidneyintelX.dkd. The Company believes these collective advancements represent entering the final stage of comprehensive United States insurance coverage.