Renalytix kidney test claims allowed by US Patent Office

Diagnostic artificial intelligence (AI) specialist Renalytix announced an enhancement to its intellectual property portfolio for its KidneyIntelX.dkd test on Friday.

The AIM-traded firm said the US Patent Office was allowing its claims regarding the biomarkers sTNFR1 and sTNFR2, which play a crucial role in the AI-enabled blood test designed to evaluate the risk of progressive kidney function decline, specifically in individuals who have type-2 diabetes and early-stage chronic kidney disease.

It said the KidneyIntelX.dkd test, which had already secured US Food and Drug Administration (FDA) de Novo marketing authorisation as of 29 June, used the specific biomarkers to identify those at an elevated risk of early kidney function decline, facilitating the implementation of therapeutic strategies for the demographic.

The board explained that the recent notice of allowance issued by the US Patent Office enhanced the foundational intellectual property of the KidneyIntelX technology by comprehensively incorporating sTNFR1 and sTNFR2 into a consolidated set of claims.

That progression would be integral for maintaining the robustness and exclusivity of Renalytix’s technology in the market.

The firm said the milestone followed the filing of the claims by the Joslin Diabetes Center.

Importantly, Renalytix holds the exclusive licence to the patent, thus safeguarding its technology and paving the way for the continued delivery of innovative solutions to diagnose and manage chronic kidney disease.

“The company believes this development reflects the Renalytix strategy of innovation in biomarker research, development and translation in collaboration with the Joslin Diabetes Center and other leading research partners globally,” the board said.

“When taken together with other key milestones, such as FDA De Novo marketing authorisation, broad insurance coverage and published clinical utility and outcomes data, Renalytix believes this increases its competitive advantage.”

The company also believed it created further barriers to entry in the large addressable market for optimising clinical management of kidney disease to drive improved patient outcomes.

“A similar strategy to protect Renalytix’s intellectual property is being pursued in Europe, which also presents a large opportunity for KidneyIntelX expansion.”

At 1245 BST, shares in Renalytix were down 8.59% at 47.99p.

Reporting by Josh White for Sharecast.com.