Manual Review Required

BRCA1/2 mutation

breast cancer · Therapy Not Normalized

BRCA1/2 mutation is flagged as manual review required because public trials show inclusion required evidence in 7 contexts. FDA CDx context should be reviewed manually.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 1

Treatment-assignment count: 0

Stratification count: 0

Threshold snippets

Fragmentation view

Threshold count: 0

Common snippets: None extracted

Threshold label: Low

FDA CDx context

Mapping summary

CDx label: Fda Cdx Context Not Found

CDx maturity score: 1/5

Confidence: Low

Patent-density signal

Diagnostic appendix

Signal count: 0

Recent signals: 0

Density label: Low

Source links

Evidence paths

https://clinicaltrials.gov/study/NCT03499353 | https://clinicaltrials.gov/study/NCT03206203 | https://clinicaltrials.gov/study/NCT02365805 | https://clinicaltrials.gov/study/NCT02681562 | https://clinicaltrials.gov/study/NCT00256217 | https://clinicaltrials.gov/study/NCT01898117 | https://clinicaltrials.gov/study/NCT07484776