The GenWay Clinical Laboratory is a San Diego based CAP accredited CLIA facility.   

GenWay’s Clinical Laboratory Services offer reliable pre-clinical study and clinical trial testing to support companion diagnostic development, a PMA submission, or a 510(k) submission.


GenWay works with your clinical, scientific, and regulatory personnel to define study objectives and specifications.  Based on your needs, we provide a project budget and a timeline with including milestone deliverables. At each milestone scheduled, we provide a progress report based on your specifications.  

Custom Service Experts

  • GenWay has extensive experience producing antibodies, protein standards, and assays for clinical applications;
  • GenWay has the assay development knowledge to take new biomarkers, develop, optimize and validate a kit in a clinical setting to meet any need that are currently unavailable through GenWay’s catalog or via other organizations.
Accreditations and Licenses
  1. CAP Accreditation
  2. California State License
  3. CLIA Certificate
  4. Medical Director License
Press Releases
  1. CLIA Press Release
  2. CAP Press Release