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🧫🧠🦠🩸🧫BIOMARKERS : measurable indicator of any biological state, https…
🧫🧠🦠🩸🧫BIOMARKERS : measurable indicator of any biological state
SAFETY BIOMARKERS
To predict toxic adverse events induced by drug , medical intervention or environmental agent exposure
Examples
Serum creatinine may be used as a safety biomarker when evaluating patients on drugs that affect kidney function to monitor for nephrotoxicity (Wasung et al. 2015).
Serum potassium may be used as a safety biomarker when evaluating patients on diuretics (decreased levels), angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or aldosterone antagonists (increased levels) (James et al. 2014; Roush and Sica 2016).
PREDICTIVE BIOMARKERS
To identify the probability of develop a clinacal event (positive or negative) after the expisure to a medical product or environmental agent
Examples
Human leukocyte antigen allele (HLA)–B*5701 genotype may be used as a predictive biomarker to evaluate human immunodeficiency virus (HIV) patients before abacavir treatment, to identify patients at risk for severe skin reactions (AIDSinfo 2007).
RESPONSES /PHARMACODYNAMIC BIOMARKERS
To evaluate the respense to a medical condition or clinical intervention
Examples
HIV-RNA reduction is a validated surrogate endpoint for human immunodeficiency virus (HIV) clinical disease control and has been used as the basis for approval of drugs intended to treat HIV (DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents 2019).
Circulating B lymphocytes may be used as a pharmacodynamic biomarker when evaluating patients with systemic lupus erythematosus to assess response to a B-lymphocyte stimulator inhibitor (Stohl and Hilbert 2012).
MOTORING BIOMARKERS
To asses presence , status or extent of a disease or medical condition to evaluate the response to the intervention
Examples
Prostate-specific antigen (PSA) may be used as a monitoring biomarker when assessing disease status or burden in patients with prostate cancer (Freedland and Moul 2007; Sandler and Eisenberger 2007; Thompson et al. 2007).
Cancer antigen 125 (CA 125) may be used as a monitoring biomarker when assessing disease status or burden during and after treatment in patients with ovarian cancer (Gundogdu et al. 2011; Rustin et al. 2001).
HIV-RNA may be used as a monitoring biomarker to measure and guide treatment with antiretroviral therapy (ART) (AIDSinfo 2007).
PROGNOSTIC BIOMARKERS
To identify the likhood of a clinical event , disease recrurrence or progression in patients diagnosed with a disease or having a medical condition
Examples
BReast CAncer genes 1 and 2 (BRCA1/2) mutations may be used as prognostic biomarkers when evaluating women with breast cancer, to assess the likelihood of a second breast cancer (Basu et al. 2015).
Chromosome 17p deletions and TP53 mutations may be used as prognostic biomarkers when evaluating patients with chronic lymphocytic leukemia, to assess the likelihood of death (Gonzalez et al. 2011; Shanafelt et al. 2006).
Increasing prostate-specific antigen (PSA) may be used as a prognostic biomarker when evaluating patients with prostate cancer during follow-up, to assess the likelihood of cancer progression (Roberts et al. 2001).
SUSCEPTIBILITY/ Risk BIOMARKERS
To mesure the risk of an individual to develop a disease or medical condition in patients without the disease or medical condition
Examples
Apolipoprotein E (APOE) gene variations may be used as susceptibility/risk biomarkers to identify individuals with a predisposition to develop Alzheimer’s disease (Chartier-Harlin et al. 1994; Genin et al. 2011).
Infection with certain human papillomavirus (HPV) subtypes may be used as a susceptibility/risk biomarker to identify individuals with a predisposition to develop cervical cancer (Khan et al. 2005; Schiffman et al. 2011).
C-reactive protein (CRP) level may be used as a susceptibility/risk biomarker to identify adult patients with a greater likelihood of incident coronary disease (Greenland et al. 2010; Pearson et al. 2003; Ridker et al. 2007; Ridker et al. 2008).
DIAGNOSTIC BIOMARKERS
To confirm the presence of a disease (and subtypes) or medical condition
Examples
Repeated blood pressure readings obtained outside the clinical setting in adults 18 years and older may be used as a diagnostic biomarker to identify those with essential hypertension (U.S. Preventive Services Task Force 2016)
Gene expression profiling may be used as a diagnostic biomarker to segregate patients with diffuse large B-cell lymphoma into subgroups with different tumor cell of origin signatures (Scott et al. 2014).
https://youtu.be/Q1CwARpnfe8
:
https://www.fda.gov/drugs/biomarker-qualification-program/about-biomarkers-and-qualification
https://youtu.be/98i7rUReD_o
