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Are there any diagnostic biomarkers?
Are there any biomarkers to identify disease progression and prognosis?
What are the markers linked to efficacy/toxicity of a drug?
Are there any biomarkers approved by regulatory authorities?
Are there any evidence based clinical practice guidelines issued by professional societies?
Is the biomarker translating from preclinical to clinical models?
What are the clinical endpoints to which a biomarker is significantly correlated?
What is the study population who would be most benefitted by a therapy?
How many clinical trials are associated with a given biomarker? What is the biomarker outcome in each trial?
What are the approved diagnostics and companion diagnostics for a given biomarker and who are the assay vendors?
What are the drug resistance biomarkers reported for a given therapy?
Are there any off-label uses of the approved drugs?
BIOMARKER UTILITIESEach biomarker is assigned with the following utilities as reported by the investigator
Biomarkers which indicate the presence or likelihood of a particular disease in
or in animal models.
Ex: Significantly elevated serum carbonic anhydrase 1 (CA1) level is reported as a novel early diagnostic biomarker in stage I non-small cell lung cancer (NSCLC) patients compared to healthy control subjects
Biomarkers which can discriminate between patients at high and low risk of a
Ex: Estrogen receptor, beta in Breast cancer
High epithelial Lysosomal-associated membrane protein 3 (LAMP3) expression is reported as a novel biomarker of poor prognosis in patients with esophageal squamous cell carcinoma
Biomarkers which can indicate the progression of disease.
Ex: Dysregulation of glutathione S-transferase pi 1 (GSTP1) is reported as novel biomarker predicting aggressive disease and disease progression in African American men with prostate cancer
Biomarkers which correlate with the desired effect of a treatment.
Ex: FEV1 is reported as a efficacy biomarker as evident by its significant improvement following treatment with MK-7123 in chronic obstructive pulmonary disease patients
Biomarkers predictive of response to a treatment.
Ex: Whole blood alpha defensin DEFA1 mRNA expression is reported as a predictive biomarker of drug response in castration-resistant prostate cancer (CRPC) patients receiving docetaxel treatment
Markers which substitute a desired clinical outcome and which can be measured
even years before meaningful clinical endpoints like mortality or morbidity.
Ex: Increased BNP is correlated with the extent of myocardial ischemia, age, renal insufficiency, and ventricular dysfunction in patients with acute coronary syndrome suggesting that BNP may be useful as a surrogate marker for multiple conventional risk factors.
Indicate potentially harmful effects of a drug in clinical population
Ex: Blood alkaline phosphatase is reported as a safety biomarker as evidenced by its increased level in 1.27% gastric cancer patients treated with ramucirumab as compared to 0% patients treated with placebo
Indicate potentially harmful effects of a drug in cell-based or preclinical
Ex: Gentamicin sulfate induced nephrotoxicity was measured in terms of significantly increased renal, urinary and serum clusterin levels respectively in adult Lewis rats after 12 days of treatment at 100 mg/kg/day
Biomarkers which can be used to indicate the pharmacokinetic properties of the
Ex: Ferritin is reported as a pharmacokinetic biomarker as evident by significant association between serum ferritin level and volume of drug distribution of non-conjugated deferiprone and urinary iron excretion in splenectomized and non-splenectomized Beta-Thalassaemia/haemoglobin E patients treated with a single oral dose of deferiprone at a dose of 25 mg/kg