From the Clinic to CDx: Navigating the Path of Clinical Trial Assay Selection & CDx Options for Targeted Oncology Therapies in Mid-Stage Development

Time: 11:30 am
day: Track B - Day 1 AM


  • Describe how an optimal clinical trial assay may be selected and discuss reimbursement, dual marketing plans
  • Explain significant risk and non-significant risk determination, IDE and pre-Sub issues
  • Understand how aspects of a biomarker assay impact recruitment, study execution (including defining a clinical cut off strategy), and transition to a CDx and PMA and transition to a CDx and PMA