BIOMARKERS: AN IMPERATIVE ACCESSION FOR DIAGNOSIS OF A DISEASE AND DRUG DEVELOPMENT
DOI:
https://doi.org/10.22159/ajpcr.2017.v10i5.17559Keywords:
Biomarkers, Disease, Pathophysiology, Therapeutics, TreatmentAbstract
Biomarkers are becoming an essential part of clinical development, not least because they offer a faster alternative to the conventional drug
development approach and the promise of safer drugs, in greater numbers, approved more quickly. Many of the failures happen late in clinical trials,
with the consequence that expenditure in clinical drug development – already a mammoth effort requiring a huge amount of money, time, and patient
is increasing. The ultimate vision is to have access to therapeutic fields, a better understanding of pathophysiology of diseases, thereby uncovering potential drug targets and biomarkers in the disease pathway. By finding molecular biomarkers of the disease, diagnosis could be improved and could reveal new information about the disease, by which a better chance for developing drugs is possible. Biomarkers can also reflect the entire spectrum of disease from the earliest manifestations to the terminal stages. In this present review, biomarkers of various diseases were enlisted to highlight the overabundance of information necessary for clinicians and scientists to have a thorough understanding of biomarkers and its ability to improve treatment and reduce health-care costs which are potentially greater than in any other area of medical research.
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References
Biomarkers Definition Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharmacol Ther 2001;69:89-95.
Strimbu K, Tavel JA. What are biomarkers? Curr Opin HIV AIDS 2010;5(6):463-6.
WHO International Programme on Chemical Safety. Biomarkers in Risk Assessment: Validity and Validation. 2001. Available from: http://www.inchem.org/documents/ehc/ehc/ehc222.htm.
WHO International Programme on Chemical Safety. Biomarkers and Risk Assessment: Concepts and Principles. 1993. Available from http://www.inchem.org/documents/ehc/ehc/ehc155.htm.
Fleming TR, DeMets DL. Surrogate end points in clinical trials: Are we being misled? Ann Intern Med 1996;125(7):605-13.
Desai M, Stockbridge N, Temple R. Blood pressure as an example of a biomarker that functions as a surrogate. AAPS J 2006;8(1):E146-52.
Gertrude H. Sergievsky Center and the Taub Institute for Research on Alzheimer’s Disease and the Aging Brain. New York: College of Physicians and Surgeons, Columbia University; 2013.
Craig-Schapiro R, Fagan AM, Holtzman DM. Biomarkers of Alzheimer’s disease. Neurobiol Dis 2009;35(2):128-40.
Mayeux R. New York. Available from: http://www.rpm2/at/columbia.edu.
U.S. Food and Drug Administration. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. Rockville, MD: U.S. Food and Drug Administration, U.S. Department of Health and Human Services; 2004. Available from: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html#execsummary.
Mayeux R, Saunders AM, Shea S, Mirra S, Evans D, Roses AD, et al. Utility of the apolipoprotein E genotype in the diagnosis of Alzheimer’s disease. Alzheimer’s disease centers consortium on apolipoprotein E and alzheimer’s disease. N Engl J Med 1998;338(8):506-11.
Schulte PA. A conceptual and historical framework for molecular epidemiology. In: Molecular Epidemiology. Principles and Practices. San Diego, CA: Academic Press; 1993. p. 3-44.
Ilyin SE, Belkowski SM, Plata-Salamán CR. Biomarker discovery and validation: Technologies and integrative approaches. Trends Biotechnol 2004;22(8):411-6.
Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, et al. Phases of biomarker development for early detection of cancer. J Natl Cancer Inst 2001;93(14):1054-61.
Barker PE. Cancer biomarker validation: Standards and process: Roles for the national institute of standards and technology (NIST). Ann N Y Acad Sci 2003;983:142-50.
Rothman N, Hainaut P, Schulte P, Smith M, Boffetta P, Perera F. Molecular Epidemiology: Principles and Practice. San Diego, California: Academic Press; 1993. p. 79-107.
Luchini A, Geho DH, Bishop B, Tran D, Xia C, Dufour RL, et al. Smart hydrogel particles: Biomarker harvesting: One-step affinity purification, size exclusion, and protection against degradation. Nano Lett 2008;8(1):350-61.
Taguchi A, Politi K, Pitteri SJ, Lockwood WW, Faça VM, Kelly-Spratt K, et al. Lung cancer signatures in plasma based on proteome profiling of mouse tumor models. Cancer Cell 2011;20(3):289-99.
Ludwig JA, Weinstein JN. Biomarkers in cancer staging, prognosis and treatment selection. Nat Rev Cancer 2005;5(11):845-56.
Catalona WJ. Clinical utility of measurements of free and total prostate-specific antigen (PSA): A review. Prostate Suppl 1996;7:64-9.
Beckett ML, Cazares LH, Vlahou A, Schellhammer PF, Wright GL Jr. Prostate-specific membrane antigen levels in sera from healthy men and patients with benign prostate hyperplasia or prostate cancer. Clin Cancer Res 1999;5(12):4034-40.
Zhenhua M, Ma Q, Wang Z. An evaluation of the diagnostic value of CA19-9 and CEA levels in patients with pancreatic cancer. J Nanjing Med Univ 2009;23:199-202.
Chen CC, Yang SH, Lin JK, Lin TC, Chen WS, Jiang JK, et al. Is it reasonable to add preoperative serum level of CEA and CA19-9 to staging for colorectal cancer? J Surg Res 2005;124(2):169-74.
Ozaksit G, Caglar T, Ciçek N, Kusçu E, Batioglu S, Gökmen O. Serum CA 125 levels before, during and after treatment for endometriosis. Int J Gynaecol Obstet 1995;50(3):269-73.
Fayed ST, Ahmad SM, Kassim SK, Khalifa A. The value of CA 125 and CA72-4 in management of patients with epithelial ovarian cancer. Dis Markers 1998;14(3):155-60.
Richardson BE, Hulka BS, Peck JL, Hughes CL, van den Berg BJ, Christianson RE, et al. Levels of maternal serum alpha-fetoprotein (AFP) in pregnant women and subsequent breast cancer risk. Am J Epidemiol 1998;148(8):719-27.
Bataille R, Grenier J, Commes T. In vitro production of beta 2 microglobulin by human myeloma cells. Cancer Invest 1988;6(3):271-7.
Cordoba F, Lavabre-Bertrand T, Salhi SL, Huguet MF, Gerfaux J, Rossi JF, et al. Spontaneous monoclonal immunoglobulin-secreting peripheral blood mononuclear cells as a marker of disease severity in multiple myeloma. Br J Haematol 2000;108(3):549-58.
Hauschild A, Engel G, Brenner W, Gläser R, Mönig H, Henze E, et al. Predictive value of serum S100B for monitoring patients with metastatic melanoma during chemotherapy and/or immunotherapy. Br J Dermatol 1999;140(6):1065-71.
Hsueh EC, Gupta RK, Glass EC, Yee R, Qi K, Morton DL. Positron emission tomography plus serum TA90 immune complex assay for detection of occult metastatic melanoma. J Am Coll Surg 1998;187(2):191-7.
Pacini F, Pinchera A. Serum and tissue thyroglobulin measurement: Clinical applications in thyroid disease. Biochimie 1999;81(5):463-7.
Elisei R. Routine serum calcitonin measurement in the evaluation of thyroid nodules. Best Pract Res Clin Endocrinol Metab 2008;22(6):941-53.
Arrieta O, Michel Ortega RM, Angeles-Sánchez J, Villarreal-Garza C, Avilés-Salas A, Chanona-Vilchis JG, et al. Serum human chorionic gonadotropin is associated with angiogenesis in germ cell testicular tumors. J Exp Clin Cancer Res 2009;28:120.
Vijay A, Gertz MA. Waldenström macroglobulinemia. Blood 2007;109(12):5096-103.
Federico M, Guglielmi C, Luminari S, Mammi C, Marcheselli L, Gianelli U, et al. Prognostic relevance of serum beta2 microglobulin in patients with follicular lymphoma treated with anthracycline-containing regimens. A GISL study. Haematologica 2007;92(11):1482-8.
Salomon DS, Brandt R, Ciardiello F, Normanno N. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995;19(3):183-232.
Sidransky D. Emerging molecular markers of cancer. Nat Rev Cancer 2002;2(3):210-9.
Hammarström S. The carcinoembryonic antigen (CEA) family: Structures, suggested functions and expression in normal and malignant tissues. Semin Cancer Biol 1999;9(2):67-81.
Shangguan D, Li Y, Tang Z, Cao ZC, Chen HW, Mallikaratchy P, et al. Aptamers evolved from live cells as effective molecular probes for cancer study. Proc Natl Acad Sci U S A 2006;103(32):11838-43.
Henderson IC, Patek AJ. The relationship between prognostic and predictive factors in the management of breast cancer. Breast Cancer Res Treat 1998;52(1-3):261-88.
Dandachi N, Dietze O, Hauser-Kronberger C. Chromogenic in situ hybridization: A novel approach to a practical and sensitive method for the detection of HER2 oncogene in archival human breast carcinoma. Lab Invest 2002;82(8):1007-14.
Molina R, Auge JM, Escudero JM, Marrades R, Viñolas N, Carcereny E, et al. Mucins CA 125, CA 19.9, CA 15.3 and TAG-72.3 as tumor markers in patients with lung cancer: Comparison with CYFRA 21-1, CEA, SCC and NSE. Tumour Biol 2008;29(6):371-80.
Landman J, Chang Y, Kavaler E, Droller MJ, Liu BC. Sensitivity and specificity of NMP-22, telomerase, and BTA in the detection of human bladder cancer. Urology 1998;52(3):398-402.
Kalantarian S, Rimm EB, Herrington DM, Mozaffarian D. Dietary macronutrients, genetic variation, and progression of coronary atherosclerosis among women. Am Heart J 2014;167(4):627-35.e1.
Shao B, Tang C, Sinha A, Mayer PS, Davenport GD, Brot N, et al. Humans with atherosclerosis have impaired ABCA1 cholesterol efflux and enhanced high-density lipoprotein oxidation by myeloperoxidase. Circ Res 2014;114(11):1733-42.
Distiller LA. Why do some patients with type 1 diabetes live so long? World J Diabetes 2014;5(3):282-7.
Mueller T, Hinterreiter F, Luft C, Poelz W, Haltmayer M, Dieplinger B. Mortality rates and mortality predictors in patients with symptomatic peripheral artery disease stratified according to age and diabetes. J Vasc Surg 2014;59(5):1291-9.
Unis A, Abdelbary A, Hamza M. Comparison of the effects of escitalopram and atorvastatin on diet-induced atherosclerosis in rats. Can J Physiol Pharmacol 2014;92(3):226-33.
Hadi NR, Mohammad BI, Ajeena IM, Sahib HH. Antiatherosclerotic potential of clopidogrel: Antioxidant and anti-inflammatory approaches. Biomed Res Int 2013;2013:790263.
Collier P, Watson CJ, Voon V, Phelan D, Jan A, Mak G, et al. Can emerging biomarkers of myocardial remodelling identify asymptomatic hypertensive patients at risk for diastolic dysfunction and diastolic heart failure? Eur J Heart Fail 2011;13:1087-95.
Kachkovskii MA, Simerzin VV, Rybanenko OA, Kirichenko NA. Hemostasiological, lipidemic, and hemodynamic indicators associated with the risk of cardiovascular death in high- and very high-risk patients according to the SCORE scale. Ter Arkh 2014;86(3):59-64.
Whelton SP, Narla V, Blaha MJ, Nasir K, Blumenthal RS, Jenny NS, et al. Association between resting heart rate and inflammatory biomarkers (High-sensitivity C-reactive protein, interleukin-6, and fibrinogen) (From the multi-ethnic study of atherosclerosis). Am J Cardiol 2014;113(4):644-9.
Rubenfire M, Brook RD. HDL cholesterol and cardiovascular outcomes: What is the evidence? Curr Cardiol Rep 2013;15(4):349.
Catapano AL, Pirillo A, Bonacina F, Norata GD. HDL in innate and adaptive immunity. Cardiovasc Res 2014;103(3):372-83.
Zampetaki A, Willeit P, Tilling L, Drozdov I, Prokopi M, Renard JM, et al. Prospective study on circulating MicroRNAs and risk of myocardial infarction. J Am Coll Cardiol 2012;60(4):290-9.
von Schacky C. Omega-3 index and cardiovascular health. Nutrients 2014;6(2):799-814.
Heringlake M, Charitos EI, Gatz N, Käbler JH, Beilharz A, Holz D, et al. Growth differentiation factor 15: A novel risk marker adjunct to the EuroSCORE for risk stratification in cardiac surgery patients. J Am Coll Cardiol 2013;61(6):672-81.
Grundy SM. Use of emerging lipoprotein risk factors in assessment of cardiovascular risk. JAMA 2012;307(23):2540-2.
Luo C, Ren H, Wan JB, Yao X, Zhang X, He C, et al. Enriched endogenous omega-3 fatty acids in mice protect against global ischemia injury. J Lipid Res 2014;55(7):1288-97.
Esposito E, Cordaro M, Cuzzocrea S. Roles of fatty acid ethanolamides (FAE) in traumatic and ischemic brain injury. Pharmacol Res 2014;86:26-31.
Hanefeld M, Duetting E, Bramlage P. Cardiac implications of hypoglycaemia in patients with diabetes - a systematic review. Cardiovasc Diabetol 2013;12:135.
Tan JS, Seow CJ, Goh VJ, Silver DL. Recent advances in understanding proteins involved in lipid droplet formation, growth and fusion. J Genet Genomics 2014;41(5):251-9.
Gupta S, Gudapati R, Gaurav K, Bhise M. Emerging risk factors for cardiovascular diseases: Indian context. Indian J Endocrinol Metab 2013;17(5):806-14.
Rich-Edwards JW, Fraser A, Lawlor DA, Catov JM. Pregnancy characteristics and women’s future cardiovascular health: An underused opportunity to improve women’s health? Epidemiol Rev 2014;36:57-70.
Hodcroft CJ, Rossiter MC, Buch AN. Cannabis-associated myocardial infarction in a young man with normal coronary arteries. J Emerg Med 2014;47(3):277-81.
Weiner SD, Ahmed HN, Jin Z, Cushman M, Herrington DM, Nelson JC, et al. Systemic inflammation and brachial artery endothelial function in the multi-ethnic study of atherosclerosis (MESA). Heart 2014;100(11):862-6.
Hurks R, Vink A, Hoefer IE, de Vries JP, Schoneveld AH, Schermerhorn ML, et al. Atherosclerotic risk factors and atherosclerotic postoperative events are associated with low inflammation in abdominal aortic aneurysms. Atherosclerosis 2014;235(2):632-41.
Oni ET, Agatston AS, Blaha MJ, Fialkow J, Cury R, Sposito A, et al. A systematic review: Burden and severity of subclinical cardiovascular disease among those with nonalcoholic fatty liver; should we care? Atherosclerosis 2013;230(2):258-67.
Nursalim A, Suryaatmadja M, Panggabean M. Potential clinical application of novel cardiac biomarkers for acute myocardial infarction. Acta Med Indones 2013;45(3):240-50.
Eggers KM, Al-Shakarchi J, Berglund L, Lindahl B, Siegbahn A, Wallentin L, et al. High-sensitive cardiac troponin T and its relations to cardiovascular risk factors, morbidity, and mortality in elderly men. Am Heart J 2013;166(3):541-8.
O’Malley RG, Bonaca MP, Scirica BM, Murphy SA, Jarolim P, Sabatine MS, et al. Prognostic performance of multiple biomarkers in patients with non-ST-segment elevation acute coronary syndrome: Analysis from the MERLIN-TIMI 36 trial (Metabolic efficiency with ranolazine for less ischemia in non-ST-elevation acute coronary syndromes-thrombolysis in myocardial infarction 36). J Am Coll Cardiol 2014;63(16):1644-53.
Humpel C. Identifying and validating biomarkers for Alzheimer’s disease. Trends Biotechnol 2011;29(1):26-32.
Liotta LA, Petricoin E. Cancer biomarkers: Closer to delivering on their promise. Cancer Cell 2011;20(30):279-80.
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