Key milestones achieved for kidneyintelX.dkd
Renalytix plc has achieved key regulatory milestones to support the scaling of its kidneyintelX.dkd test, including the successful transfer of laboratory operations to a new facility in New York which increases testing capacity by over 3.5x and is projected to save over $2.6 million on a net present value basis over five years. Additionally, the company has completed the submission for CE marking of kidneyintelX.dkd, a crucial step for its use in global pharma clinical trials and potential commercialization in European markets, with the CE marking process expected to finalize in Q3 2026.
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- Submission of Technical Review for the CE marking of kidneyintelX.dkd completed
LONDON and NEW YORK, 22 April 2026 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a precision medicine diagnostics company, with kidneyintelX.dkd, the only FDA-approved and Medicare reimbursed prognostic test to support early-stage risk assessment in chronic kidney disease, announces the successful completion of the transfer of laboratory operations to a state of the art facility in New York.
The new facility significantly enhances operational capability, increasing testing capacity by more than 3.5x and providing a scalable infrastructure to support growth to in excess of 100,000 tests per annum. This expanded capacity positions the Company to efficiently meet growing demand and support broader commercial adoption. Execution of the transfer included comprehensive analytical validation of the kidneyintelX.dkd assay and regulatory inspection of the facility by the New York State Department of Health.
The transition also delivers immediate cost efficiencies, materially reducing the Company's fixed cost base in the near term, with the potential to generate substantial longer-term value with expected cost savings of over $2.6 million on a net present value basis over five years. The reduced cost base is expected to deliver immediate gross margin gains and drive meaningful operating leverage as testing volumes scale.
Additionally, the Company announces that it has completed, to schedule, the submission for CE marking of the technical file for kidneyintelX.dkd. As previously announced, achievement of CE marking is a core strategy to enable use of kidneyintelX.dkd in global pharma clinical trials while at the same time, enabling commercialisation of kidneyintelX.dkd in certain European markets. The Company expects to finalise the CE marking process in Q3 2026 with initial testing of patients and data generation from the Steno Diabetes Center expected in Q4 2026 and expanding to services revenue generating testing at multiple sites in 2027.
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