Comprehensive in vitro diagnostic support

Mayo Clinic BioPharma Diagnostics provides in vitro diagnostic-specific services to support medical device, biopharma, and diagnostic companies by conducting analytical validation of new assays and devices in compliance with CAP/CLIA requirements.

Supported by more than 160 laboratory medicine and pathology physicians and scientists, our team facilitates discussions with laboratory and disease experts to help ensure your analytical method development and validation needs align with the latest scientific and regulatory requirements.

Strategic partnerships to propel test development


600 projects supported through Mayo Clinic BioPharma Diagnostics engagements


60+ CAP and CLIA labs offer testing services that align with FDA IVD regulatory parameters

Insider access

A partnership with Mayo Clinic BioPharma Diagnostics offers access to Mayo Clinic Laboratories’ core competencies, including:

  • Assay development
  • Access to biospecimens
  • Analytical validation services

End-to-end support

Powered by Mayo Clinic Laboratories’ expansive testing menu, Mayo Clinic BioPharma Diagnostics not only advances precision medicine, but serves as a strategic partner at every phase of the research and development journey.

By leveraging the clinical and research assay development capabilities of Mayo Clinic, we organize a team of laboratory, medical, and business professionals to collaborate, develop, and launch tests specific to every partner’s therapeutic strategy.

With three Mayo Clinic campuses and a health system spanning three states, Mayo Clinic BioPharma Diagnostics can facilitate multistate testing and/or prospective sample collection to support clinical trials and diagnostic validation projects.

BioPharma Diagnostics Laboratory: Research and investigational in vitro diagnostic development activities

Our flexible lab space provides resources needed for assay development, instrument or assay kit validation projects, remnant sample acquisition, and co-development opportunities.

Learn more about how we can work together.