Dr. Morteza Minaee

Vice President of Regulatory Affairs at Guardant Health

Dr. Morteza Minaee has more than 25 years of experience in the FDA-regulated medical devices and global diagnostic industry leading regulatory, quality-systems, and clinical-affairs organizations.

He is currently Vice President of Regulatory Affairs at Guardant Health in Red Wood City California. Prior to Guardant Health he served as Senior Director, Regulatory Affairs at Roche leading many FDA clearances in digital pathology applications including breast cancer biomarkers.

He also held senior positions in Regulatory, Clinical Affairs, and Quality for companies such as Abbott Molecular and Siemens Healthcare. He holds a doctorate in law and policy from Northeastern University, and MS in administration from Boston University.


Title: Regulatory considerations for Next Generation Sequencing (NGS)-based circulating tumor DNA (ctDNA) as biomarker candidates into companion diagnostics

  • Evolving Regulatory environment for NGS and Cancer Comprehensive Genomic Profiling
  • ctDNA assays- Challenges and opportunities
  • ctDNA intended uses and indications- A changing model
  • Analytical Performance Studies Consideration
  • Clinical Validation Considerations
    • Three Alternative Pathways
      • Method Comparison Approach
      • Retrospective Clinical Bridging Approach
      • Prospective patient enrollment Approach