Role evidence
Usage summary
Strongest role: Inclusion Required
Inclusion-required count: 2
Treatment-assignment count: 0
Stratification count: 0
Low Public Signal
HER2 / ERBB2 amplification
solid tumor basket · Therapy Not Normalized
HER2 / ERBB2 amplification is flagged as low public signal because public trials show inclusion required evidence in 5 contexts. FDA CDx context should be reviewed manually.
Threshold snippets
Fragmentation view
Threshold count: 1
Common snippets: HER2 IHC 2+
Threshold label: Low
FDA CDx context
Mapping summary
CDx label: Fda Cdx Context Manual Review Required
CDx maturity score: 2/5
Confidence: Medium
Patent-density signal
Diagnostic appendix
Signal count: 0
Recent signals: 0
Density label: Low
Source links
Evidence paths
https://clinicaltrials.gov/study/NCT00095563 | https://clinicaltrials.gov/study/NCT07617805 | https://clinicaltrials.gov/study/NCT02208583 | https://clinicaltrials.gov/study/NCT06383884 | https://clinicaltrials.gov/study/NCT00357617