Know Your Companions™
A unified map of FDA-defined biomarker requirements by indication. For solid tumors, tumor-agnostic biomarkers appear inline to show where they apply across multiple cancer types.
Approvals
215
Therapies
84
Biomarkers
54
Mapped tests
58
Showing 40 Indications
Acute Myeloid Leukemia (AML)
Oncology • Leukemia
Heme indication3 biomarkers · 6 therapies · 3 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| FLT3 (ITD/TKD) | ITD mutations and TKD mutations D835 and I836 | , , |
| IDH1 | R132 mutations (R132C, R132H, R132G, R132S, and R132L) | , |
| IDH2 | R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S, and R172W |
Aggressive Systemic Mastocytosis
Oncology • Mastocytosis
Heme indication1 biomarker · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| KIT | D816V |
Anaplastic Thyroid Cancer (ATC)
Oncology • Thyroid
Solid tumor indication8 biomarkers · 6 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRAF | V600E |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Astrocytoma and Oligodendroglioma
Oncology • Brain
Solid tumor indication9 biomarkers · 6 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| IDH1, IDH2 | IDH1 R132C, IDH1 R132G, IDH1 R132H, IDH1 R132L, IDH1 R132S, IDH2 R172M, IDH2 R172K, IDH2 R172W, IDH2 R172S, and IDH2 R172G mutations |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
B-cell Chronic Lymphocytic Leukemia (CLL)
Oncology • Leukemia
Heme indication1 biomarker · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| TP53 | Deletion chromosome 17p (17p-) |
Biliary Tract Cancer
Oncology • Biliary
Solid tumor indication8 biomarkers · 6 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| ERBB2 (HER2) | HER-2 protein overexpression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Breast Cancer
Oncology • Breast
Solid tumor indication12 biomarkers · 15 therapies · 14 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRCA1 and BRCA2 | alterations (including mutations) | , |
| ERBB2 (HER2) | gene amplification | , , |
| HER-2 protein overexpression | , , | |
| HER2 ultralow expression (IHC 0 with membrane staining) | ||
| HER2-low expression (IHC 1+ or IHC 2+/ISH non-amplified) | ||
| ESR1 | ESR1 missense mutations between codons 310 and 547 | |
| PIK3CA | AKT1/PTEN alterations | |
| alterations (including mutations) | ||
| C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Cervical Cancer
Oncology • Cervix
Solid tumor indication8 biomarkers · 5 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| PD-L1 | protein expression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Cholangiocarcinoma
Oncology • Bile Duct
Solid tumor indication9 biomarkers · 7 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| FGFR2 | fusions and select rearrangements | |
| IDH1 | Single nucleotide variants |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Chronic Myeloid Leukemia (CML)
Oncology • Leukemia
Heme indication1 biomarker · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| t(9;21) Philadelphia chromosome | BCR-ABL fusion |
Colorectal Cancer (CRC)
Oncology • Colorectal
Solid tumor indication18 biomarkers · 12 therapies · 14 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2 | Microsatellite instability-High (MSI-H) | , |
| BRAF | V600E | |
| EGFR (HER1) | protein expression | , |
| KRAS | G12A, G12D, G12R, G12C, G12S, G12V, G13D | , |
| G12C | , | |
| KRAS wild-type (absence of mutations in codons 12 and 13) | , | |
| Mutations in codons 12 and 13 of KRAS gene | , | |
| KRAS and NRAS | wild-type (absence of mutations in exons 2, 3 and 4) |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , , , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Duchenne Muscular Dystrophy (DMD)
Neurology • Muscle
1 biomarker · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| AAV Antibodies | serotype rh74 |
Endometrial Carcinoma (EC)
Oncology • Endometrium
Solid tumor indication9 biomarkers · 7 therapies · 5 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| Not MSI-High | Not Microsatellite Instability-High (Not MSI-H) | |
| proficient mismatch repair (pMMR) proteins | MLH1, PMS2, MSH2 and MSH6 |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Oncology • Ovary/Peritoneum
Solid tumor indication8 biomarkers · 6 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| FOLR1 | protein expression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Esophageal Squamous Cell Carcinoma (ESCC)
Oncology • Esophagus
Solid tumor indication8 biomarkers · 5 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| PD-L1 | protein expression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Follicular Lymphoma Tumor
Oncology • Lymphoma
Heme indication1 biomarker · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| EZH2 | Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 gene |
Gastric and Gastroesophageal Cancer
Oncology • Stomach/GEJ
Solid tumor indication8 biomarkers · 6 therapies · 7 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| ERBB2 (HER2) | gene amplification | |
| HER-2 protein overexpression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Oncology • Stomach/GEJ
Solid tumor indication9 biomarkers · 6 therapies · 7 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| Claudin 18 (CLDN18) | Claudin 18 (CLDN18) protein expression (≥75% viable tumor cells (% TC) staining) | |
| PD-L1 | protein expression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Gastrointestinal Stromal Tumors (GIST)
Oncology • GIST
Solid tumor indication8 biomarkers · 6 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| PDGFRA | D842V mutation |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Head and Neck Squamous Cell Carcinoma (HNSCC)
Oncology • Head & Neck
Solid tumor indication8 biomarkers · 5 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| PD-L1 | protein expression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Hemophilia A Patients
Hematology • Blood
1 biomarker · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| AAV Antibodies | serotype 5 |
Hemophilia A patients with or without factor VIII inhibitors and Hemophilia B patients with or without IX inhibitors
Hematology • Blood
2 biomarkers · 2 therapies · 2 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| Antithrombin III | Functionally active Antithrombin III | |
| Concizumab | Tissue factor pathway inhibitor antagonist |
Low-Grade Glioma
Oncology • Brain
Solid tumor indication8 biomarkers · 6 therapies · 5 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRAF | V600 and BRAF fusions |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Medullary Thyroid Cancer (MTC)
Oncology • Thyroid
Solid tumor indication7 biomarkers · 5 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| RET | RET mutations (SNVs, MNVs, and deletions) |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Melanoma
Oncology • Melanoma
Solid tumor indication8 biomarkers · 12 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRAF | V600 | |
| V600E | , | |
| V600E and V600K | , , , | |
| V600E or V600K | , |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Oncology • Prostate
Solid tumor indication11 biomarkers · 9 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRCA1 and BRCA2 | alterations (including mutations) | , , , |
| BRCA1, BRCA2 and ATM | alterations (including mutations) | |
| Homologous recombination repair (HRR) genes | BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D and RAD54L alterations |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Metastatic Colorectal Cancer (mCRC)
Oncology • Colorectal
Solid tumor indication8 biomarkers · 6 therapies · 5 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRAF | V600E |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Moderate to severe Hemophilia B patients
Hematology • Blood
1 biomarker · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| AAV Antibodies | serotype rh74 |
Myelodysplastic Syndromes (MDS)
Oncology • Bone Marrow
Heme indication2 biomarkers · 2 therapies · 2 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| IDH1 | R132 mutations (R132C, R132H, R132G, R132S, and R132L) | |
| PDGFRB | PDGFRB gene rearrangement at 5q31~33 |
Non-Small Cell Lung Cancer (NSCLC)
Oncology • Lung
Solid tumor indication15 biomarkers · 32 therapies · 20 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| ALK | gene rearrangements | , , , , |
| protein expression | , , , | |
| BRAF | V600E | , |
| EGFR (HER1) | Exon 19 deletion or exon 21 L858R substitution mutation | , , , , , |
| Exon 19 deletions or exon 21 L858R, and T790M | ||
| Exon 20 insertions | , | |
| L861Q, G719X and S7681 | ||
| T790M | ||
| ERBB2 (HER2) | Activating Mutations (SNVs And Exon 20 Insertions) | |
| Activating mutations in the tyrosine kinase domain (SNVs in exons 18-21 and exon 20 insertions) | ||
| KRAS | G12C | , |
| MET | MET protein expression (>= 50% of tumor cells exhibiting strong membrane and/or cytoplasmic staining 3+) | |
| single nucleotide variants and indels that lead to MET exon 14 skipping | , | |
| PD-L1 | protein expression | , |
| protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]) | ||
| protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%]) | ||
| protein expression (tumor cell staining ≥1%) | ||
| protein expression [Tumor Proportion Score (TPS) ≥ 50%] | ||
| ROS1 | fusions | , |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | , |
| TMB | TMB ≥ 10 mutations per megabase |
Non-Transfusion-Dependent Thalassemia
Hematology • Blood
1 biomarker · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| Liver iron concentration imaging | based on the proton transverse relaxation rate of MRI images |
Obesity
Endocrinology • Metabolic
3 biomarkers · 1 therapy · 1 mapped test
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| POMC, PCSK1 and LEPR | Variants (Pathogenic/Likely Pathogenic) and Variants of Uncertain Significance |
Ovarian Cancer
Oncology • Ovary
Solid tumor indication10 biomarkers · 7 therapies · 7 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRCA1 and BRCA2 | alterations (including mutations) | , |
| HRD | Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes and/or positive Genomic Instability Score |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Pancreatic Cancer
Oncology • Pancreas
Solid tumor indication9 biomarkers · 6 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRCA1 and BRCA2 | alterations (including mutations) |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Prostate Cancer
Oncology • Prostate
Solid tumor indication9 biomarkers · 6 therapies · 5 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| BRCA1 and BRCA2 | alterations (including mutations) |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Synovial sarcoma
Oncology • Soft Tissue
Solid tumor indication9 biomarkers · 6 therapies · 7 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| HLA | Eligible alleles: HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 and their P-group alleles. Exclusion alleles: HLA-A*02:05 and its P-group alleles. | |
| Melanoma-associated antigen 4 (MAGE-A4) | MAGE-A4 protein overexpression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Thyroid Cancer (TC)
Oncology • Thyroid
Solid tumor indication7 biomarkers · 5 therapies · 6 mapped tests
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Triple-Negative Breast Cancer (TNBC)
Oncology • Breast
Solid tumor indication8 biomarkers · 5 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| PD-L1 | protein expression |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Urothelial Cancer
Oncology • Bladder
Solid tumor indication9 biomarkers · 7 therapies · 7 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| FGFR3 | Exon 7: R248C (c.742C>T), S249C (c.746C>G); exon 10: G370C (c.1108G>T) and Y373C (c.1118A>G); and fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) | |
| PD-L1 | protein expression (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area) |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |
Uveal Melanoma
Oncology • Eye
Solid tumor indication8 biomarkers · 6 therapies · 6 mapped tests
Indication-specific biomarkers
Select a therapy to open its FDA-approved testing pathway
| Biomarker | Biomarker details | Therapies |
|---|---|---|
| HLA | HLA-A*02:01 |
Tumor-agnostic biomarkers that apply to this indication
Solid tumors| Biomarker | Biomarker details | Therapies |
|---|---|---|
| deficient mismatch repair (dMMR) proteins | MLH1, PMS2, MSH2 and MSH6 | , |
| MSI-High | Microsatellite instability-High | , |
| NTRK1, NTRK2 and NTRK3 | fusions | , |
| RET | fusions | |
| TMB | TMB ≥ 10 mutations per megabase |