CIViC Compass

FDA-based clinical actionability for genomic alterations. Actionable = FDA labeling + FDA CDx only.

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89FDA-actionable assertions

112+Targeted therapies

42+Tumor types covered

FDA onlyData sourceFDA prescribing labels and companion diagnostic (CDx) approvals only — no experimental or off-label data

Sensitivity — FDA-indicated treatments

NSCLC

EGFR exon 19 deletionEGFR L858REGFR T790MKRAS G12CALK fusionROS1 fusionRET fusionMET exon 14 skippingPD-L1 high expression (TPS >= 50%)EGFR exon 20 insertionERBB2 (HER2) activating mutationNRG1 gene fusionEGFR uncommon mutations (G719X / S768I / L861Q)EGFR uncommon mutations (G719X / S768I / L861Q)

Other

TMB-High (>=10 mut/Mb)NTRK gene fusionFGFR2/3 mutation or fusion (urothelial)VHL mutation / lossSomatostatin receptor positive (SSTR+)CD30-positiveMYD88 L265P mutation (Waldenström's)EZH2 activating mutationNF1 mutation (plexiform neurofibroma)FRα / FOLR1 high expression (platinum-resistant ovarian cancer)BRAF V600E (pediatric low-grade glioma)CTNNB1 / β-catenin pathway (desmoid tumor)

Breast

BRCA1/2 pathogenic variantHER2 amplification / overexpressionPIK3CA mutationHormone receptor positive (ER+/PR+)ESR1 ligand-binding domain mutationGermline BRCA1/2 mutation (HER2-negative breast cancer)HER2-low breast cancer (IHC 1+ or IHC 2+/ISH-)AKT1 E17K mutationPTEN loss / mutation

AML

FLT3 ITDIDH1 R132 mutationIDH2 R140/R172 mutationPML::RARA fusion (APL)FLT3 TKD (D835/I836)KMT2A rearrangementNPM1 mutation

Colorectal

MSI-H / dMMRKRAS G12C (colorectal cancer)BRAF V600E (colorectal cancer)HER2 amplification / overexpression

CML

BCR::ABL1 fusion (Ph+)BCR::ABL1 T315IBCR::ABL1 T315I

Prostate

PSMA-positive (prostate cancer)HRR gene mutation (mCRPC)BRCA1/2 mutation (first-line mCRPC — PARP + AR combination)

Cholangiocarcinoma

FGFR2 fusion / rearrangementIDH1 mutation (cholangiocarcinoma)

GIST

KIT or PDGFRA mutation (GIST)PDGFRA D842V mutation (GIST)

Thyroid

RET mutation (medullary thyroid cancer)BRAF V600E (thyroid cancer)

Glioma

IDH1/IDH2 mutation (grade 2 glioma)IDH1/IDH2 mutation

MDS

Deletion 5qSF3B1 mutation / ring sideroblasts (MDS)

Melanoma

BRAF V600E

Myelofibrosis

JAK2 V617F / CALR / MPL mutation (MPN)

Basal cell carcinoma

Hedgehog pathway activation

Gastric

HER2 overexpression / amplification (gastric or GEJ adenocarcinoma)

Systemic mastocytosis

KIT D816V mutation

Myeloid/lymphoid

FGFR1 rearrangement (myeloid/lymphoid neoplasms)

Tumor-agnostic

HER2 IHC 3+ solid tumor

CLL

TP53 deletion / del(17p)

GEP-NET

SSTR2 expression

Resistance & Pharmacogenomics

Oncology resistance

EGFR exon 20 insertion — resistance to standard EGFR TKIsKRAS any mutation (colorectal)NRAS any mutation (colorectal)EGFR T790M — resistance to 1st/2nd gen TKIsBRAF non-V600 — resistance to vemurafenibHER2-negative — trastuzumab not indicatedUGT1A1 *28 — irinotecan toxicityBCR::ABL1 T315IRAS any mutation (colorectal)KRAS any mutation — panitumumab resistanceBRAF V600E — anti-EGFR resistance (colorectal)

Pharmacogenomics

DPYD *13 — fluoropyrimidine toxicityTPMT reduced activity — thiopurine toxicityNUDT15 reduced activity — thiopurine toxicityG6PD deficiencyDPYD *2A — fluoropyrimidine toxicityTPMT / NUDT15 deficiency — thiopurine toxicityUGT1A1 *28 — belinostat toxicity

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