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Biomarkers

Biomarker evidence, labeled by type

322 biomarkers with an FDA companion diagnostic, curated cancer actionability or other curated evidence, grouped by evidence tier. Free to read.

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FDA companion diagnostic FDA companion diagnostic 62 FDA qualification project FDA qualification project 104 Cancer actionable (CGI) Cancer actionable (CGI) 156 FDA companion diagnostic FDA companion diagnostic 62 FDA qualification project FDA qualification project 104 Cancer actionable (CGI) Cancer actionable (CGI) 156

Biomarker pages per tier

FDA companion diagnostic 62

An FDA-cleared or approved companion diagnostic names this biomarker.

FDA companion diagnostic biomarkers
Biomarker Kind
ERBB2 Gene
EGFR Gene
KRAS Gene
BRAF Gene
PD-L1 Protein expression
BRCA1 Gene
BRCA2 Gene
ALK Gene
PIK3CA Gene
RET Gene
ESR1 Gene
IDH1 Gene
MET Gene
Deficient mismatch repair (dMMR) Molecular signature
NRAS Gene
NTRK1 Gene
NTRK2 Gene
ROS1 Gene
FLT3 (ITD/TDK) Source-defined biomarker
Homologous recombination repair gene panel Biomarker panel
MSI-High Molecular signature
IDH2 Gene
NTRK3 Gene
PTEN Gene
HLA Source-defined biomarker
NTRK3 fusions Source-defined biomarker
Myriad HRD Molecular signature
ACVR2A Gene
AKT1 Gene
ATM Gene
BTBD7 Gene
DIDO1 Gene
EZH2 Gene
FGFR2 Gene
FGFR3 Gene
FOLR1 Gene
KIT Gene
KMT2A Gene
LEPR Gene
MRE11 Gene
PCSK1 Gene
PDGFRA Gene
PDGFRB Gene
POMC Gene
RYR3 Gene
SEC31A Gene
SULF2 Gene
TP53 Gene
AAVrh74 Source-defined biomarker
AAVRh74var capsid neutralizing antibodies Source-defined biomarker
Anti-AAV5 Antibodies Source-defined biomarker
Antithrombin III Source-defined biomarker
Circulating tumor DNA (ctDNA) molecular residual disease (MRD) Source-defined biomarker
Concizumab Source-defined biomarker
Melanoma-associated antigen 4 (MAGE-A4) Source-defined biomarker
Claudin 18 expression Protein expression
Liver iron concentration imaging Imaging biomarker
Microsatellite stable (MSS) Molecular signature
Not MSI-High Molecular signature
Philadelphia chromosome Cytogenetic feature
Proficient mismatch repair (pMMR) Molecular signature
Tumor mutation burden (TMB) Molecular signature

FDA qualification project 104

An FDA Biomarker Qualification Program project names this biomarker.

FDA qualification project biomarkers
Biomarker Kind
Safety biomarker to be used with traditional indicators to indicate renal injury in rat as measured by assay Source-defined biomarker
Artificial Intelligence-Based Histologic Measurement of NASH (AIM-NASH) System Source-defined biomarker
Biomarker endpoint to be used in clinical trials to evaluate drugs and/or vaccines intended to treat or prevent Plasmodium falciparum in endemic areas Source-defined biomarker
Biomarker for inflammatory bowel disease (IBD) patients quantifying activated neutrophils in serum and plasma Source-defined biomarker
Biomarkers for in vitro developmental toxicity screening in a human system Source-defined biomarker
Coronary artery non-calcified plaque volume (NCPV) for detection and quantification of atherosclerotic CAD Source-defined biomarker
CPa9-HNE: A minimally invasive biomarker reflecting neutrophil activity Source-defined biomarker
Development of diagnostic biomarkers for determination of traumatic brain injury Source-defined biomarker
Diagnostic biomarker to enrich and to identify patients likely to have histopathologic findings of nonalcoholic steatohepatitis (NASH) Source-defined biomarker
Diagnostic biomarker to enrich clinical trials by reduction of Autism Spectrum Disorder (ASD) associated heterogeneity Source-defined biomarker
Diagnostic biomarker to pre-screen patients with clinical risk factors for chronic liver disease for enrollment in clinical trials to identify those at high risk of having histopathologic findings of significant fibrosis Source-defined biomarker
Diagnostic biomarker to select a less heterogenous subgroup within subjects with autism spectrum disorder (ASD) for clinical trial enrichment Source-defined biomarker
Diagnostic biomarker used with other clinical and host factors to identify patients with Invasive Aspergillosis as measured by assay Source-defined biomarker
Diagnostic biomarker, used with other clinical indicators, to confirm a diagnosis of small fiber polyneuopathy in drug development studies Source-defined biomarker
Diagnostic enrichment biomarker for selecting patients for non-alcoholic steatohepatitis trials Source-defined biomarker
Diagnostic enrichment biomarker to identify patients likely to have liver histopathologic findings of non-alcoholic steatohepatitis (NASH) Source-defined biomarker
Diagnostic enrichment biomarker used in conjunction with clinical risk factors to identify patients more likely to have liver histopathologic findings of Nonalcoholic steatohepatitis (NASH) Source-defined biomarker
Diagnostic NASH biomarker for clinical trial enrichment by modified aptamer technology on the SomaScan Platform Source-defined biomarker
Diffusion MRI-Based Biomarker for Parkinsonism Differentiation and Progression Prediction Source-defined biomarker
Diffusion-weighted magnetic resonance imaging (DW-MRI) as a predictive imaging biomarker of radiation response and oncologic outcomes in head and neck cancer Source-defined biomarker
Digital pathology biomarker to aid in assessing fibrosis severity in adult patients with MASH Source-defined biomarker
Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) as an imaging biomarker of mandibular radiation injury/osteoradionecrosis Source-defined biomarker
Free-water diffusion MRI-based diagnosis of Alzheimer's patients with neuroinflammation Source-defined biomarker
Functional Respiratory Imaging (FRI) of Lung and Airway Structural and Functional Parameters Measured by Low-dose High-definition Volumetric Computerized Tomography (HDCT) Scans and Quantitative Imaging Technology Source-defined biomarker
Glx BIOMARKER FOR DEPRESSION AND SUICIDALITY Source-defined biomarker
HepQuant DSI as a Reasonably Likely Surrogate Endpoint (RLSE) for Clinical Outcome in Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) Source-defined biomarker
High-resolution diffusion Magnetic Resonance Imaging measure called fixel-based apparent fiber density specifically in the fornix Source-defined biomarker
Imaging Biomarkers for Diagnosis of Nonalcoholic Steatohepatitis (NASH) Source-defined biomarker
Imaging safety biomarkersk(he) and k(bh)to aid identification of drugs that may cause Drug Drug Interactions Source-defined biomarker
Ketamine induced pharmaco-BOLD response as a Pharmacodynamic/Response (PD/R) biomarker for early-stage clinical studies of glutamate-targeted treatments for schizophrenia Source-defined biomarker
Liver Stiffness Measurement by VCTE as Surrogate Endpoint for MASH with Fibrosis Source-defined biomarker
Liver Stiffness Measurement (LSM) by Magnetic Resonance Elastography (MRE) as a Reasonably Likely Surrogate Endpoint (RLSE) Source-defined biomarker
Measurement of emphysema progression in clinical trialsas measured by computed tomographic (CT)scans, specifically the volume-adjusted lungdensity measurementat the 15thpercentile of the lung CT histogram (VALDPerc 15, g/L) Source-defined biomarker
MindFront IMPHYS Integrated Multimodal Physiological Biomarker in Alzheimer's Disease and Related Dementias Research Source-defined biomarker
Monitoring biomarker for drug induced vascular injury (DIVI) to measure inflammation, vascular endothelial and smooth muscle damage Source-defined biomarker
Monitoring biomarker informs initiation of treatment with anti-malarial drug following controlled human malaria infection with Plasmodium falciparum sporozoites in healthy subjects from endemic areas Source-defined biomarker
Monitoring biomarker informs initiation of treatment with anti-malarial drug following controlled human malaria infection (CHMI) with P. falciparum sporozoites in healthy subjects in clinical studies for vaccine and/or drug development. Source-defined biomarker
Monitoring biomarker, used with other parameters, for correlation with changes in idiopathic pulmonary fibrosis status in drug development studies Source-defined biomarker
MRI-based white matter measures as surrogate endpoints in Alzheimer’s disease Source-defined biomarker
MRI Relaxometry for Muscle Radioinjury Source-defined biomarker
Neurofilament Light (NF-L) Polypeptide in Plasma Source-defined biomarker
Neurotoxicity Biomarker as Assessed by MRI T2 Relaxation Source-defined biomarker
Non-invasive MRI-based liver fibrosis biomarker Source-defined biomarker
Perivascular spaces (PVS) as assessed by brain Magnetic Resonance Imaging (MRI) scan Source-defined biomarker
Pharmacodynamic Biomarker for Monitoring NASH Treatment Response Source-defined biomarker
Pharmacodynamic biomarker to accelerate evaluations of novel treatment of NSCLC (lung cancer) and DLBCL (lymphoma) Source-defined biomarker
Pharmacodynamic Biomarker to Assess Pathological Response in Neoadjuvant Therapies Source-defined biomarker
Pharmacodynamic biomarker used in NASH clinical trials to assess efficacy and change in disease severity by providing an early indication of response to treatment Source-defined biomarker
Pharmacodynamic Biomarker used in Primary Sclerosing Cholangitis (PSC) Clinical Trial Source-defined biomarker
Pharmacodynamic/response biomarker for Crohn’s disease used as a co-primary endpoint Source-defined biomarker
Pharmacodynamic/response biomarker to assess drug intervention in future clinical treatment trials of Progeria Source-defined biomarker
Pharmacodynamic response biomarker to assess treatment response in patients with pulmonary tuberculosis Source-defined biomarker
Pharmacodynamic/response biomarker to assess tumor volume change for new oncologic drug clinical trial therapy of solid tumors Source-defined biomarker
Pharmacodynamic/Response biomarker to indicate biologic activity of a medical product in the brain Source-defined biomarker
Predictive biomarker for certain subject's opioid use disorder to enrich buprenorphine trials. Source-defined biomarker
 Predictive biomarker for subjects who are more likely to respond to anti-inflammatory treatments Source-defined biomarker
Presence and concentration of specific isomiRs identified by sRNA-Find indicate disease stage of Huntington's Disease. Source-defined biomarker
PRO-C6 is a proposed prognostic biomarker1 to provide an objective measure of risk of outcomes in clinical trials of patients with heart failure with preserved ejection fraction (HFpEF) Source-defined biomarker
Probability score for developing end-stage knee osteoarthritis (p‑esKOA) as a prognostic biomarker panel f Source-defined biomarker
Prognostic biomarker intended for use in clinical trials to enrich for individuals most likely to progress to full psychosis and poor long-term functional outcomes Source-defined biomarker
Prognostic biomarker to identify patients likely to experience long-term knee osteoarthritis disease progression. Source-defined biomarker
Prognostic biomarker to predict the four-year risk of cardiovascular outcomes (Residual Cardiovascular Risk (RCVR) Test) Source-defined biomarker
Prognostic biomarker used with other characteristics to enrich for COPD exacerbations Source-defined biomarker
Prognostic biomarker, used with other testing, to categorize kidney transplant recipients’ risk of graft rejection for enrichment or stratification in drug development studies Source-defined biomarker
Prognostic biomarker with patient age and baseline glomerular filtration rate for Autosomal Dominant Polycystic Kidney Disease Source-defined biomarker
Prognostic biomarkers to identify patients more likely to experience knee osteoarthritis disease progression Source-defined biomarker
Prognostic enrichment biomarker panel to identify individuals with a diagnosis of knee osteoarthritis who are likely to experience disease progression Source-defined biomarker
Prognostic enrichment biomarker to identify NASH patients more likely to experience clinical endpoints such as progression to cirrhosis, hepatic decompensation events during the timeframe of a NASH clinical trial Source-defined biomarker
Prognostic enrichment biomarker to identify patients likely to experience long-term knee osteoarthritis disease progression Source-defined biomarker
Prognostic enrichment imaging biomarker to identify individuals with a diagnosis of knee osteoarthritis who are likely to experience disease progression Source-defined biomarker
PROLIFIC Risk Score: Multi-Biomarker Prognostic Tool for Idiopathic Pulmonary Fibrosis Source-defined biomarker
Proposed use of PRO-C3 as a prognostic biomarker to provide an objective measure of risk of survival outcomes in clinical trials of patients with solid tumors. Source-defined biomarker
Protein-based Biomarker for Antidepressant Drug Development Source-defined biomarker
Radiologic Biomarker to assess lesional iron content in cavernous angiomas with symptomatic hemorrhage (CASH) Source-defined biomarker
Reasonably likely surrogate endpoint for use in clinical trials to support evaluation of immunosuppressive therapy applications Source-defined biomarker
Response biomarker used as a surrogate endpoint for survival time in studies of castration resistant metastatic prostate cancer Source-defined biomarker
RS ratio® as a Reasonably Likely Surrogate Endpoint for Tuberculosis Drug Development Source-defined biomarker
Safety biomarker for arrhythmia risk assessment Source-defined biomarker
Safety biomarker panel to aid in the detection of kidney tubular injury in phase 1 trials in healthy volunteers Source-defined biomarker
Safety biomarker panel to aid in the detection of acute drug induced skeletal muscle injury in phase 1 trials Source-defined biomarker
Safety biomarker panel to assess whether a drug has caused mild injury response in the renal tubules in normal healthy volunteers and patients with normal renal function Source-defined biomarker
Safety biomarker panel to detect acute drug-induced pancreatitis in Phase 1 trials Source-defined biomarker
Safety biomarker panel to detect acute drug-induced kidney injury risk in Phase 1 trials Source-defined biomarker
Safety biomarker score to assess pre-clinical risk identification of drug induced pro-arrhythmia (torsades de pointes) Source-defined biomarker
Safety biomarker to assess drug-induced liver injury Source-defined biomarker
Safety biomarker to assess drug induced liver injury Source-defined biomarker
Safety biomarker to detect acute drug-induced central nervous system (CNS) injury risk in Phase 1 trials Source-defined biomarker
Safety biomarker to identify drug-induced liver injury biomarker panel Source-defined biomarker
Safety biomarker to identify in-vitro mammalian cell structural chromosomal damage Source-defined biomarker
Safety biomarkers for monitoring drug induced vascular injury (DIVI) in early clinical development Source-defined biomarker
Safety serum/plasma cardiotoxicity biomarkers as assessed by immunoassay Source-defined biomarker
Second Harmonic Generation (SHG) and Machine-Learning based Model for a Stain-free Measurement of Fibrosis (qFibrosis) in Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Source-defined biomarker
Second Harmonic Generation (SHG) and Machine-Learning based Modelfor a Stain-free Measurement of Fibrosis (qFibrosis) in Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Source-defined biomarker
Serum biomarkers of drug-induced liver Injury as assessed by multiple assays Source-defined biomarker
Serum Free Copper as a prognostic biomarker for conversion from mild cognitive impairment (MCI) to symptomatic Alzheimer’s disease Source-defined biomarker
Serum non-ceruloplasmin copper (Free Copper) Source-defined biomarker
Study and use of neurofilament light (NfL) chain measured in plasma or serum as an exploratory pharmacodynamic/response biomarker for early clinical trials in progressive multiple sclerosis (MS) Source-defined biomarker
Study strategy for generic Nusinersen Sodium injection based on PSG-209531 Source-defined biomarker
Surrogate endpoint used to assess the clinical endpoints of hip and non-vertebral fracture risk reduction Source-defined biomarker
Susceptibility/risk biomarker for trials targeting presymptomatic stages of NSD (Stage 2 and Stage 1) Source-defined biomarker
Susceptibility/risk biomarker to identify individuals more likely to develop type 1 diabetes Source-defined biomarker
Translational safety biomarkers to detect and monitor drug-induced pancreatic injury Source-defined biomarker
Web-based Automated Imaging Differentiation of Parkinsonism Source-defined biomarker
Wound Size Measurement Using a Handheld Imaging Device Source-defined biomarker

Cancer actionable (CGI) 156

Curated as clinically actionable in cancer by the Cancer Genome Interpreter.

Cancer actionable (CGI) biomarkers
Biomarker Kind
NF1 Gene
NF2 Gene
ABL1 Gene
STK11 Gene
MAP2K1 Gene
AR Gene
FLT3 Gene
NOTCH1 Gene
MTOR Gene
DPYD Gene
TPMT Gene
BAP1 Gene
CDK4 Gene
CDKN2A Gene
ERBB3 Gene
PALB2 Gene
RB1 Gene
CD274 Gene
CDK6 Gene
CRBN Gene
JAK2 Gene
MYC Gene
PIK3CB Gene
SH2B3 Gene
TSC1 Gene
TSC2 Gene
ARID1A Gene
ATR Gene
ERCC1 Gene
RAF1 Gene
UGT1A1 Gene
CCND1 Gene
CDKN2B Gene
CDKN2C Gene
CRLF2 Gene
ERBB4 Gene
FBXW7 Gene
FGFR1 Gene
GNAQ Gene
HRAS Gene
IL7R Gene
MAP2K2 Gene
NOTCH2 Gene
PML Gene
PTCH1 Gene
VHL Gene
ARAF Gene
BCL2 Gene
CTNNB1 Gene
DDR2 Gene
EPHA2 Gene
G6PD Gene
GNA11 Gene
JAK1 Gene
PBRM1 Gene
POLE Gene
SMARCB1 Gene
SMO Gene
AKT3 Gene
ANXA1 Gene
AURKA Gene
BTK Gene
CBL Gene
CCND2 Gene
CDK12 Gene
CDKN1A Gene
CDKN1B Gene
CHEK2 Gene
CYP17A1 Gene
FANCA Gene
FANCC Gene
FGF3 Gene
FGF4 Gene
FLCN Gene
HGF Gene
INPP4B Gene
JAK3 Gene
KCNJ5 Gene
LRP1B Gene
MDM2 Gene
NPM1 Gene
NRG1 Gene
PIK3R1 Gene
PRKCH Gene
RAD50 Gene
SETD2 Gene
SLC44A4 Gene
SMARCA4 Gene
SUZ12 Gene
SYK Gene
TMPRSS2 Gene
AKT2 Gene
APC Gene
AREG Gene
B2M Gene
BCL6 Gene
BCOR Gene
CA9 Gene
CCND3 Gene
CCNE1 Gene
CD69 Gene
CDH1 Gene
CSF1R Gene
CSF3R Gene
DNMT3A Gene
EPHA3 Gene
ERCC2 Gene
ERCC4 Gene
ERCC6 Gene
EREG Gene
FAT1 Gene
FGFR4 Gene
FLT1 Gene
FOXA1 Gene
FRS2 Gene
GATA3 Gene
GLI2 Gene
GNAS Gene
HDAC2 Gene
HIF1A Gene
IGF1R Gene
IGF2 Gene
KDR Gene
KMT2D Gene
MCL1 Gene
MDM4 Gene
MITF Gene
MKI67 Gene
MPL Gene
MSH3 Gene
MYCN Gene
MYD88 Gene
NUTM1 Gene
PAK1 Gene
PDGFB Gene
PDPK1 Gene
PIK3R2 Gene
PLCG2 Gene
PTPRD Gene
RAC1 Gene
RAD51C Gene
RICTOR Gene
RNF43 Gene
SERPINB3 Gene
SF3B1 Gene
SLC29A1 Gene
SMARCA1 Gene
SRSF2 Gene
STAG2 Gene
TERT Gene
TOP2A Gene
TUBB3 Gene
U2AF1 Gene
VEGFA Gene
ZBTB16 Gene
ZNRF3 Gene