CDx Development and Commercialization

Burning Rock offers integrated companion diagnostic development services for biopharma partners to streamline the co-development and commercialization of targeted drugs and respective CDx (including registration testing, clinical evaluation and finally obtain registration certificates). Our US-based lab and R&D team provide additional services to promote drug and CDx co-development worldwide.

  • Product development

  • Registration testing

  • Clinical validation

  • Product registration

  • CDx overseas development

    Product development and registration (FDA)
  • Product development
  • Raw material selection and preparation
  • Production procedure evaluation
  • Technical requirements proposal
  • Product stability evaluation
  • Product validation analyses
  • Cut off value and coverage assessment
  • Standardized production procedure
  • Registration testing
  • Document review
  • Sampling and submission to testing agency
  • Testing and data review
  • Testing report
  • Clinical validation
  • Validates whether the product can meet its intended use
  • Clinical accuracy: safety and effectiveness
  • Intended use as a CDx product
  • Product registration (NMPA)
  • Document review
  • Technical evaluation
  • Inspection of the applicant’s quality management system
  • Submission of supplementary materials
  • Approval and certification
  • Registration alteration (if applicable) or renewal

Precision companion

diagnostic strategies

  • Product development and registration (FDA)
  • In hospital marketing channels
  • Online marketing promotion channels
  • CDx developmnet
  • CDx validation
  • Patient Screening