We hold ourselves to a

Our clinical laboratories are fully licensed to provide KidneyIntelX 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 laboratories are 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 laboratories are ISO 13485 certified, meeting Quality System requirements that ensure high quality testing. It also ensures that we meet customer and regulatory requirements.

Our clinical laboratories are 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 laboratories will also pursue CAP ISO 15189 accreditation in the near future to further demonstrate competence in delivering timely and reliable test results.