Manual Review Required

MSI-H / dMMR

solid tumor basket · Therapy Not Normalized

MSI-H / dMMR is flagged as manual review required because public trials show inclusion required evidence in 39 contexts. FDA CDx context should be reviewed manually.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 16

Treatment-assignment count: 0

Stratification count: 1

Threshold snippets

Fragmentation view

Threshold count: 61

Common snippets: MSI-H | BRAF V600E | MSI-H

Threshold label: Moderate

FDA CDx context

Mapping summary

CDx label: Fda Cdx Context Manual Review Required

CDx maturity score: 2/5

Confidence: Low

Patent-density signal

Diagnostic appendix

Signal count: 0

Recent signals: 0

Density label: Low

Source links

Evidence paths

https://clinicaltrials.gov/study/NCT07259889 | https://clinicaltrials.gov/study/NCT03762447 | https://clinicaltrials.gov/study/NCT07617818 | https://clinicaltrials.gov/study/NCT04906382 | https://clinicaltrials.gov/study/NCT07208136 | https://clinicaltrials.gov/study/NCT05723562 | https://clinicaltrials.gov/study/NCT06475599 | https://clinicaltrials.gov/study/NCT07374809 | https://clinicaltrials.gov/study/NCT07431073 | https://clinicaltrials.gov/study/NCT07552376 | https://clinicaltrials.gov/study/NCT04242199 | https://clinicaltrials.gov/study/NCT07140679 | https://clinicaltrials.gov/study/NCT04165772 | https://clinicaltrials.gov/study/NCT07240857 | https://clinicaltrials.gov/study/NCT03059823 | https://clinicaltrials.gov/study/NCT06762405 | https://clinicaltrials.gov/study/NCT06640049 | https://clinicaltrials.gov/study/NCT06898450 | https://clinicaltrials.gov/study/NCT06897527 | https://clinicaltrials.gov/study/NCT03941574 | https://clinicaltrials.gov/study/NCT04443543 | https://clinicaltrials.gov/study/NCT04291248 | https://clinicaltrials.gov/study/NCT07593144 | https://clinicaltrials.gov/study/NCT05855200 | https://clinicaltrials.gov/study/NCT06686576 | https://clinicaltrials.gov/study/NCT07413146 | https://clinicaltrials.gov/study/NCT03833661 | https://clinicaltrials.gov/study/NCT04450901 | https://clinicaltrials.gov/study/NCT06278857 | https://clinicaltrials.gov/study/NCT07163403 | https://clinicaltrials.gov/study/NCT05301764 | https://clinicaltrials.gov/study/NCT06215677 | https://clinicaltrials.gov/study/NCT04393454 | https://clinicaltrials.gov/study/NCT02497820 | https://clinicaltrials.gov/study/NCT05255653 | https://clinicaltrials.gov/study/NCT05961709 | https://clinicaltrials.gov/study/NCT03053466 | https://clinicaltrials.gov/study/NCT05001516 | https://clinicaltrials.gov/study/NCT05707676