Cdx Established Context

HER2 / ERBB2 expression

ovarian cancer · Monoclonal Antibody

HER2 / ERBB2 expression is flagged as cdx established context because public trials show inclusion required evidence in 1 contexts. FDA CDx context exists.

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: 5

Common snippets: HER2 IHC 3+ | HER2 IHC 3+ | HER2 IHC 3+

Threshold label: Moderate

FDA CDx context

Mapping summary

CDx label: Fda Cdx Context Exists

CDx maturity score: 5/5

Confidence: High

Patent-density signal

Diagnostic appendix

Signal count: 0

Recent signals: 0

Density label: Low

Source links

Evidence paths

https://clinicaltrials.gov/study/NCTBIO004