Renalytix (AIM:RENX) completed the transfer of its laboratory operations to a state‑of‑the‑art facility in New York, increasing testing capacity by more than 3.5x and establishing infrastructure the company says can scale beyond 100,000 tests per annum.
The move included comprehensive analytical validation of the kidneyintelX.dkd assay and inspection by the New York State Department of Health. Renalytix says the transition will materially reduce its fixed cost base and deliver immediate gross margin gains and operating leverage as volumes rise, with expected cost savings of over $2.6 million on a net present value basis across five years.
Separately, Renalytix has completed the submission of the Technical Review for CE marking of kidneyintelX.dkd. The company expects to finalise the CE marking process in Q3 and begin initial patient testing and data generation with Steno Diabetes Center in Q4, expanding to revenue‑generating testing at multiple sites in 2027.
"kidneyintelX.dkd is the only FDA-approved and Medicare-reimbursed prognostic tool capable of understanding a patient's risk with diabetic kidney disease early where treatment has maximal effect," Renalytix added.
