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Burning Rock offers integrated companion diagnostic (CDx) development services for biopharma partners
Product Development
  • Raw material & preparation
  • Production procedure evaluation
  • Technical requirements proposal
  • Product stability evaluation
  • Product validation analyses
  • Cut-off value & coverage assesment
  • Standardized production procedure
Registration Testing
  • Raw material & preparation
  • Production procedure evaluation
  • Document review
  • Sampling and submission to testing agency
  • Testing and date review
  • Registration testing report
Clinical Evaluation
  • Raw material & preparation
  • Production procedure evaluation
  • Validates whether the product can meet its intended use
  • Clinical accuracy:safety & effectiveness
  • Intended use as a CDx product
Product Registration (NMPA)
  • Raw material & preparation
  • Production procedure evaluation
  • Document review
  • Technical evaluation
  • Inspection of the applicant's quality management system
  • Submission of supplementary materials
  • Approval & certification
  • Registration alteration(if applicable) or renewal
Global Network Operation System
  • Professional Cross-functional Team
  • Operational Excellence
  • Transparent Quality Control and Reaction Systems on Abnormal
  • International Logistics and Chain of Custody
  • Customized Documentation Services for Clinical Trails
Companion Diagnostics Partners
Burning Rock and Abbisko Therapeutics Announce Strategic Partnership on Co-development of Companion Diagnostics for ABSK091
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Burning Rock and IMPACT Therapeutics Announce a Global Strategic Partnership for Companion Diagnostics Development
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Burning Rock and CStone Pharmaceuticals reached a strategic collaboration on the co-development of companion diagnostics for pralsetinib in China
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Merck KGaA, Darmstadt, Germany and Burning Rock Collaborate on Liquid-biopsy Based CDx Development Using Burning Rock’s OncoCompass™ Target
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Burning Rock announced a China collaboration with AstraZeneca
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Burning Rock and Boehringer Ingelheim Achieved a Master Service Agreement in Oncology Companion Diagnostics
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We Could Offer More

Genomic Data Solutions

Clinical Trial Solutions

CDx Development & Commercialization

Precision Patient Recruitment
Contact Our Experts
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