Why Is Kidney-Disease Diagnostic Focused Renalytix Stock Trading Higher Today?

Thursday, Renalytix plc RNLX announced that effective March 1, 2024, the United States Government has approved adding the company’s FDA de Novo Marketing authorized test, kidneyintelX.dkd, to its 10-year Governmentwide Acquisition Contract for early-stage kidney disease bioprognostic testing services. 

Pricing for kidneyintelX.dkd is set at $950 per reportable result, the company noted in its SEC filing.

Effective through 2031 and offered through the General Services Administration, the contract covers laboratory testing services provided by any government healthcare facility, including the U.S. Veterans Administration, Department of Defense military branches.

In addition, National Government Services (NGS), a Medicare Administrative Contractor, 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, representatives from Renalytix and third-party external experts will speak in support of coverage policy DL39726 for KidneyIntelX and kidneyintelX.dkd testing.

During the meeting, the presenters will share data to demonstrate the clinical value of KidneyIntelX from studies enrolling 9,000 patients.

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 the issuance of a final Local Coverage Determination (LCD) during the 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 Clinical Lab Fee Schedule.

These advancements are expected to facilitate insurance reimbursement for 10 million of the 14 million patients in the United States who fall within the FDA-authorized indication for the use of kidneyintelX.dkd.

Price Action: RNLX shares are up 32.50% at $1.10 on the last check Thursday.

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