Companion Diagnostic Co-Development for New Imaging Brain Scans or as Outcome Measures
- How can sponsors and tracer makers team up (for example, the widely used but still investigational Lantheus tau tracer) to collect validation data side-by-side with regulatory approval in mind for patient pre-selection
- How co-developing can enable the label to specify a clear uptake cut-off instead of treating “everyone”
- Use of Hippocampal volume as eligibility criterion and as an outcome measure in APOE-4 carriers with AD
- Partnering early avoids the hold-up when the diagnostic lags behind, allowing doctors to use the scan on launch day to pick the right patients