Data SecurityElise Wilfinger2023-02-07T16:43:10+00:00

measures.

All KidneyIntelX^TM testing is conducted exclusively at a Renalytix clinical laboratory, under both CLIA certification and ISO/IEC 27001 Certified Information Security Management System, which provides a model for establishing, implementing, operating, monitoring, reviewing, maintaining and improving an information security management system (ISMS).

All patient data is secured in our proprietary database and the Lab Information Management System (LIMS), software designed to improve lab productivity and efficiency, by automating workflows and keeping track of data associated with samples, experiments and instruments. Further, LIMS conducts a QA/QC on all lab results generated each day.

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KidneyIntelX is a Laboratory Developed Test (LDT) that yields a custom risk score identifying adult patients with type 2 diabetes and chronic kidney disease stages 1-3, who are at low, intermediate or high risk for rapid disease progression within a period of up to five years. It is regulated by the Centers for Medicare and Medicaid Services (CMS) in CLIA-certified laboratories. The KidneyIntelX test is currently used for clinical and commercial purposes; It should not be regarded as only investigational or for research purposes.

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