Latest Research In Biomarker

Research No-1

Biomarkers as drug development tools: discovery, validation, qualification and use

The 21st Century Cures Act, approved in the USA in December 2016, has encouraged the establishment of the national Precision Medicine Initiative and the augmentation of efforts to address disease prevention, diagnosis and treatment on the basis of a molecular understanding of disease. The Act adopts into law the formal process, developed by the FDA, of qualification of drug development tools, including biomarkers and clinical outcome assessments, to increase the efficiency of clinical trials and encourage an era of molecular medicine. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic. Biomarkers that are used exclusively for the diagnosis, monitoring or stratification of patients in clinical trials are not subject to regulatory approval, although their qualification can facilitate the conduct of a trial. In this Review, the salient features of biomarker discovery, analytical validation, clinical qualification and utilization are described in order to provide an understanding of the process of biomarker development and, through this understanding, convey an appreciation of their potential advantages and through this understanding, convey an appreciation of their potential advantages and limitations.

Research No-2

Enzymatic and Non-enzymatic Biomarkers Levels in Pregnancy Trimesters in Ilesa South Western Nigeria

Aims: The aim of this study was to see the effect of pregnancy on some selected enzymatic and non-enzymatic biomarkers based on trimesters.

Study Design: One-factor, one control - three test group quasi - experimental design.

Place and Duration of Study: Department of Chemical Pathology, Obafemi Awolowo University Teaching Hospitals Complex, Wesley Guild Hospital Unit, Ilesa, Osun State, Nigeria, between September 2015 and April 2016.

Methodology: A total of eighty (80) subjects were recruited for the study, and were grouped into 1sttrimester pregnant women (n=20), 2nd trimester pregnant women (n=20), 3rd trimester pregnant women (n=20), and non-pregnant women (n=20). Blood samples (10 mL venous blood) were collected, centrifuged and stored as plasma before subjection to biochemical analysis. Blood plasma was analyzed for enzymatic and non-enzymatic biomarkers using standard approved methods.

Results: This study revealed that from first to third trimester, the following biomarkers: CK (creatine-kinase), LDH (lactate dehydrogenase), GGT (gamma-glutamyl transferase), AMY (amylase), TRP (troponin), CRP (c-reactive protein), MYO (myoglobin), AFP (alphafetoprotein), CB (conjugated bilirubin), and UR (urea) progressively increased while AST (aspartate aminotransferase), ALT (alanine aminotransferase), ALP (alkaline phosphatase), TB (total bilirubin), CR (creatinine), Na+ (sodium),and K+ (potassium) gradually decreases respectively. TP (total protein), and ALB (albumin), decreases in first and second trimester before rising in the third trimester of pregnancy. Moreover, in statistical analysis of the pregnancy trimesters with non pregnant women, ALP, AMY, TRP, MYO, and AFP were significantly increased while UR was significantly decreased in first trimester comparison with control subjects. In second trimester of pregnancy, CK, LDH, ALP, AMY, TRP, CRP, MYO, and AFP, were significantly elevated while UR was significantly decreased when compared to non pregnant subjects. In third trimester of pregnancy, CK, LDH, ALP, GGT, AMY, TRP, CRP, MYO, AFP, and CB were significantly raised while Na+ was significantly reduced when compared to the non pregnant women. Other biomarkers investigated with controls has differences that were statistically non significant.

Conclusion: Pregnancy irrespective of the trimester exerts positive influence on both enzymatic and non enzymatic biomarkers, which when investigated during pregnancy prevent pregnancy associated medical complications and gives improved antenatal care for safe delivery of a healthy baby by healthy mother.

Research No-3

Changes in the Oxidative Stress Biomarkers in Liver of Streptozotocin-diabetic Rats Treated with Combretum lanceolatum Flowers Extract

Aims: The study investigated the in vivo antioxidant activity and the in vitro radical scavenging capacity of the Combretum lanceolatum Pohl (Combretaceae) flowers ethanolic extract (ClEtOH) in streptozotocin-diabetic rats. Place and Duration of Study: Department of Chemistry, Federal University of Mato Grosso, Cuiabá, Brazil; between February 2012 and December 2012. Methodology: Male Wistar rats were divided into four groups: Normal rats treated with water/vehicle (N); diabetic rats treated with water (DC); diabetic rats treated with 250 mg/kg (DT250) or with 500mg/kg (DT500) of ClEtOH. After 21 days of treatment, liver samples were used for the analysis of the oxidative stress biomarkers and activity of antioxidant enzymes. In vitro radical scavenger capacity was investigated by the following methods: DPPH radical scavenging, ABTS radical cation decolorization and crocin bleaching assays. Results: Significant oxidative stress was observed in liver of DC, since the malondialdehyde (MDA, biomarker of lipoperoxidation) levels were increased in comparison with N. Increased activities of the antioxidant enzymes superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) were also observed in DC, which could represent a compensatory mechanism against oxidative stress. Glutathione (GSH) levels were lower and similar between N and DC. The MDA levels were significantly decreased in liver of rats from DT250 and DT500, reaching levels similar those of N, suggesting that ClEtOH prevented lipoperoxidation. The treatment of diabetic rats with ClEtOH also increased the GSH levels, as well as increased the GSH-Px activity, and did not change the SOD activity. The results of in vitro radical scavenging capacity indicated that ClEtOH is highly active. Conclusion: These findings indicate that ClEtOH has antioxidant properties in liver of diabetic rats, decreasing lipoperoxidation and increasing the endogenous antioxidant responses. Both the antihyperglycemic effect and the capacity to scavenge free radicals may be related to the antioxidant activity of ClEtOH in diabetes.

Research No-4

Biomarkers in Medicine: An Overview

Recently, biomarkers in medicine have gained comprehensive scientific and clinical interest. Biomarker or biological marker defined as alteration in the constituents of tissues or body fluids provide a powerful approach to understanding the spectrum of chronic diseases with application in at least 5 areas like screening, diagnosis, prognostication, prediction of disease recurrence and therapeutic monitoring. Therefore, biomarkers are biological indicators of diseases that can be measured either in vivo by biomedical imaging or in vitro by laboratory methods. Many kinds of biomarkers are available in the field of medical science with lots of positive as well as negative effect. These markers can also reflect the entire spectrum of disease from the earliest manifestations to the terminal stages and will become one of the major driving forces of pharmaceutical research and drug development in the coming years. Generally, a biomarker is potentially useful along the whole spectrum of the disease process- before diagnosis; for screening and risk assessment, during diagnosis; for staging, grading and selecting the initial therapy and during treatment for monitoring therapy, selecting additional therapy or monitoring recurrent diseases. This brief review describes the types and major uses of biomarkers in clinical investigation.

Research No-5

microRNA based prognostic biomarkers in pancreatic Cancer

Despite tremendous research efforts focused on diagnosis and treatment, pancreatic ductal adenocarcinoma remains the third leading cause of cancer-related death in the United States, with a 5-year overall survival rate of less than 5%. Although resistance is rather complex, emerging evidence has demonstrated that epigenetic alterations (e.g. miRNA) have important roles in PDAC progression as well as resistance to therapy. Certain miRNAs have been identified as potential prognostic biomarkers in PDAC. In this review, we summarize the recent developments in miRNA research related to PDAC therapeutic resistance mechanisms and the potential of miRNAs as prognostic biomarkers for future clinical management of PDAC.

limitations.