Renalytix test gets US Medicare coverage determination

Renalytix announced on Friday that Medicare has issued a final local coverage determination (LCD) for its ‘kidneyintelX.dkd’ testing.

The AIM-traded firm said the determination, effective for services from 1 August, set the established Medicare price for the test at $950.

It said the final LCD included distinct common procedural terminology (CPT) codes for kidneyintelX.dkd, as published in the 2024 Clinical Lab Fee Schedule.

The company said the coverage specified in the LCD applied to patients with diagnosed type-2 diabetes and stage 1-3b chronic kidney disease, deeming the use of kidneyintelX.dkd as reasonable and necessary.

It noted that the specified limitations for use were consistent with the US Food and Drug Administration (FDA) label for kidneyintelX.dkd.

The LCD was issued by National Government Services (NGS), a subsidiary of Elevance Health, and a Medicare administrative contractor responsible for processing claims for testing conducted in Renalytix's New York City laboratory.

This Medicare coverage determination made for a significant milestone for the firm, meeting the prerequisites for growing test adoption, including FDA authorisation, clinical outcomes data, inclusion in clinical guidelines, and broad insurance coverage.

“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,” said chief executive officer James McCullough.

“We expect this Medicare coverage will prompt additional major coverage decisions and help accelerate testing adoption.

“We remain focused on incremental sales growth in targeted US regions with a now significantly lower cost of operations.”

At 0828 BST, shares in Renalytix were up 4.92% at 17.05p.

Reporting by Josh White for Sharecast.com.