(Alliance News) - Renalytix PLC on Friday said Medicare had issued a final local coverage determination for its kidney testing kit, kidneyintelX.dkd.

The kidneyintelX.dkd test provides risk-ratings for patients with chronic kidney disease and type-2 diabetes and establishes the possibility of rapid kidney function decline.

The London-based diagnostics company focused on the management and testing of kidney disease said the LCD was effective from August 1 with an established Medicare price for kidneyintelX.dkd of USD950 per test.

Medicare issued the LCD on Thursday, Renalytix noted.

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, Renalytix said.

In February, Renalytix said that the US government had approved kidneyintelX.dkd, to its government-wide acquisition contract for early-stage kidney disease bioprognostic testing services.

The contract covers laboratory testing services provided by any government healthcare facility, including the US Veterans Administration, Department of Defense military branches, and Indian Health Services.

In June 2023, the test received regulatory approval from the US Food & Drug Administration.

"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 [US] living with diabetes and kidney disease. We expect this Medicare coverage will prompt additional major coverage decisions and help accelerate testing adoption," said Renalytix Chief Executive James McCullough.

"We remain focused on incremental sales growth in targeted US regions with a now significantly lower cost of operations," he added.

Shares in Renalytix rose 12% to 18.20 pence in London on Friday.

By Jeremy Cutler, Alliance News reporter

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