Diagnostics are different. Pearl Pathways manages the entire diagnostic development cycle, from target selection and assay design/development/implementation to 510k/PMA development and global product launch. Our vast expertise allows us to broadly serve IVD, imaging, software, and companion diagnostics.


Pearl Pathways’ responsive experts understand the nuances that differentiate diagnostics from other therapeutic products. Our history of supporting diagnostics includes but is not limited to:


  • In vitro diagnostics (IVD)
  • Imaging
  • Software
  • Companion
  • Point-of-care

Pearl Pathways advances diagnostic development cycles for both early stage pre-commercialization companies and multinational organizations. To learn more about how we can support the development, validation, design, and submission of your diagnostic with the appropriate regulatory body, please see our full list of services.