Our clinical laboratory is fully state licensed, CLIA certified, ISO certified and CAP accredited.
Our clinical laboratory is fully licensed to provide KidneyIntelX and kidneyintelX.dkd testing services for patients in all 50 states, including New York State which required an extensive review of the analytical validation results for KidneyIntelX by Department of Health scientists.
Our clinical laboratory is CLIA certified by the Centers for Medicare and Medicaid Services (CMS), demonstrating high quality laboratory testing: accuracy, reliability, and timeliness of patient test results.
Our clinical laboratory is ISO 13485 certified, meeting Quality System requirements that ensure high quality testing. It also ensures that we meet customer and regulatory requirements.
Our clinical laboratory is CAP accredited, which is only granted when physical laboratory spaces (including everything from instrumentation and ventilation to protection for hazardous conditions) and Quality Management Systems (including test system validations and Quality Control of pre-analytic, analytic and post-analytic processes) have met CAP’s rigorous standards and passed CAP’s on-site inspections. Accreditation also acknowledges those select laboratories that can more quickly evolve to adhere to changes in lab technology.
Our clinical laboratory is in New York.
All KidneyIntelX and kidneyintelX.dkd tests are processed at our Renalytix lab.
Renalytix Clinical Laboratory New York
101 6th Avenue, 3rd Fl
New York, NY 10013