Biomarker Insights最新文献

{"title":"Are We Using Ezetimibe As Much As We Should?","authors":"Antonis A Manolis, Theodora A Manolis, Dimitri P Mikhailidis, Antonis S Manolis","doi":"10.1177/11772719241257410","DOIUrl":"10.1177/11772719241257410","url":null,"abstract":"<p><p>Lipid-lowering therapies, particularly non-statin regimens, are underutilized as ~2/3 of patients with atherosclerotic cardiovascular (CV) disease (CVD) are not optimally managed, and do not attain target low-density lipoprotein cholesterol (LDL-C) concentrations, despite statin treatment. Statins have been the mainstay of hypolipidemic therapies; however, they are plagued by adverse effects, which have partly hindered their more widespread use. Ezetimibe is often the first added mode of treatment to attain LDL-C goals as it is efficacious and also allows the use of a smaller dose of statin, while the need for more expensive therapies is obviated. We herein provide a comprehensive review of the effects of ezetimibe in lipid lowering and reducing CV events and improving outcomes. Of the hypolipidemic therapies, oral ezetimibe, in contrast to newer agents, is the most convenient and/or affordable regimen to be utilized as mono- or combined therapy supported by data from CV outcomes studies attesting to its efficacy in reducing CVD risk and events. When combined with a statin, the statin dose could be lower, thus curtailing side-effects, while the hypolipidemic effect is enhanced (by ~20%) as the percentage of patients with target level LDL-C (<70 mg/dL) is higher with combined treatment versus a high-intensity statin. Ezetimibe could also serve as an alternative treatment in cases of statin intolerance. In conclusion, ezetimibe has an excellent safety/tolerability profile; it is the first added treatment to a statin that can attain LDL-C targets. In the combined therapy, the hypolipidemic effect is enhanced while the dose of statin could be lower, thus limiting the occurrence of side-effects. Ezetimibe could also serve as an alternative mode of treatment in cases of statin intolerance.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"19 ","pages":"11772719241257410"},"PeriodicalIF":3.8,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11143858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141201012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Evolving Landscape of Biomarkers for Immune Checkpoint Blockade in Genitourinary Cancers.","authors":"Seema Mustafa, Caroline S Jansen, Yash Jani, Sean Evans, Tony Z Zhuang, Jacqueline Brown, Bassel Nazha, Viraj Master, Mehmet Asim Bilen","doi":"10.1177/11772719241254179","DOIUrl":"10.1177/11772719241254179","url":null,"abstract":"<p><p>In the past decade, immune checkpoint inhibitors (ICI) have been approved for treatment of genitourinary malignancies and have revolutionized the treatment landscape of these tumors. However, despite the remarkable success of these therapies in some GU malignancies, many patients' tumors do not respond to these therapies, and others may experience significant side effects, such as immune-related adverse events (iRAEs). Accordingly, biomarkers and improved prognostic tools are critically needed to help predict which patients will respond to ICI, predict and mitigate risk of developing immune-related adverse events, and inform personalized choice of therapy for each patient. Ongoing clinical and preclinical studies continue to provide an increasingly robust understanding of the mechanisms of the response to immunotherapy, which continue to inform biomarker development and validation. Herein, we provide a comprehensive review of biomarkers of the response to immunotherapy in GU tumors and their role in selection of therapy and disease monitoring.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"19 ","pages":"11772719241254179"},"PeriodicalIF":3.8,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11143877/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141201737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Analysis of Biomarkers in Type 2 Diabetes Patients With and Without Comorbidities: Insights Into the Role of Hypertension and Cardiovascular Disease.","authors":"Symeon Savvopoulos, Haralampos Hatzikirou, Herbert F Jelinek","doi":"10.1177/11772719231222111","DOIUrl":"https://doi.org/10.1177/11772719231222111","url":null,"abstract":"<p><strong>Background: </strong>Type 2 diabetes mellitus (T2DM) are 90% of diabetes cases, and its prevalence and incidence, including comorbidities, are rising worldwide. Clinically, diabetes and associated comorbidities are identified by biochemical and physical characteristics including glycemia, glycated hemoglobin (HbA1c), and tests for cardiovascular, eye and kidney disease.</p><p><strong>Objectives: </strong>Diabetes may have a common etiology based on inflammation and oxidative stress that may provide additional information about disease progression and treatment options. Thus, identifying high-risk individuals can delay or prevent diabetes and its complications.</p><p><strong>Design: </strong>In patients with or without hypertension and cardiovascular disease, as part of progression from no diabetes to T2DM, this research studied the changes in biomarkers between control and prediabetes, prediabetes to T2DM, and control to T2DM, and classified patients based on first-attendance data. Control patients and patients with hypertension, cardiovascular, and with both hypertension and cardiovascular diseases are 156, 148, 61, and 216, respectively.</p><p><strong>Methods: </strong>Linear discriminant analysis is used for classification method and feature importance, This study examined the relationship between Humanin and mitochondrial protein (MOTSc), mitochondrial peptides associated with oxidative stress, diabetes progression, and associated complications.</p><p><strong>Results: </strong>MOTSc, reduced glutathione and glutathione disulfide ratio (GSH/GSSG), interleukin-1β (IL-1β), and 8-isoprostane were significant (<i>P</i> < .05) for the transition from prediabetes to t2dm, highlighting importance of mitochondrial involvement. complement component 5a (c5a) is a biomarker associated with disease progression and comorbidities, gsh gssg, monocyte chemoattractant protein-1 (mcp-1), 8-isoprostane being most important biomarkers.</p><p><strong>Conclusions: </strong>Comorbidities affect the hypothesized biomarkers as diabetes progresses. Mitochondrial oxidative stress indicators, coagulation, and inflammatory markers help assess diabetes disease development and provide appropriate medications. Future studies will examine longitudinal biomarker evolution.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"19 ","pages":"11772719231222111"},"PeriodicalIF":3.8,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11069335/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140866967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Role of Methylated Circulating Tumor DNA in Combination With Pathological Prognostic Factors for Predicting Recurrence of Colorectal Cancer.","authors":"Hiba Al Naji, Jean M Winter, Susanne K Pedersen, Amitesh Roy, Susan E Byrne, Graeme P Young, Erin L Symonds","doi":"10.1177/11772719241232870","DOIUrl":"10.1177/11772719241232870","url":null,"abstract":"<p><strong>Background: </strong>Colorectal cancer (CRC) has a high rate of recurrence, in particular for advanced disease, but prognosis based on staging and pathology at surgery can have limited efficacy. The presence of circulating tumor DNA (ctDNA) at diagnosis could be used to improve the prediction for disease recurrence.</p><p><strong>Objectives: </strong>To assess the impact of detecting methylated <i>BCAT1/IKZF1</i> ctDNA at diagnosis in combination with demographic, lifestyle, clinical factors and tumor pathology, to assess predictive value for recurrence.</p><p><strong>Design: </strong>A retrospective cohort study.</p><p><strong>Methods: </strong>The cohort included 180 patients (36 with recurrent CRC), who had undergone complete treatment and surveillance for a minimum of 3 years. Participant clinical details and ctDNA methylated <i>BCAT1</i>/<i>IKZF1</i> results were compared between those with and without recurrence, and cox regression analysis assessed each factor on disease-free survival.</p><p><strong>Results: </strong>Clinical factors independently associated with reduced disease-free survival included nodal involvement (HR = 3.83, 95% CI 1.56-9.43, <i>P</i> = .003), M1 stage (HR = 4.41, 95% CI 1.18-16.45, <i>P</i> = .027), a resection margin less than 2 mm (HR = 4.60, 95% CI 1.19-17.76, <i>P</i> = .027), perineural involvement (HR = 2.50, 95% CI 1.01-6.17, <i>P</i> = .047) and distal tumors (HR = 3.13, 95% CI 1.07-9.18, <i>P</i> = .037). Methylated <i>BCAT1</i>/<i>IKZF1</i> was detected in 51.7% (93/180) of pre-treatment plasma samples. When a positive ctDNA finding was considered in combination with these clinical prognostic factors, there was improved predictive power of recurrence for patients with perineural involvement (HR = 4.44, 95% CI 1.92-10.26, <i>P</i> < .001), and it marginally improved the predictive factor for M1 stage (HR = 7.59, 95% CI 2.30-25.07, <i>P</i> = .001) and distal tumors (HR = 5.04, 95% CI 1.88-13.49, <i>P</i> = .001).</p><p><strong>Conclusions: </strong>Nodal invasion, metastatic disease, distal tumor site, low resection margins and perineural invasion were associated with disease recurrence. Pre-treatment methylated ctDNA measurement can improve the predictive value for recurrence in a subset of patients, particularly those with perineural involvement.</p><p><strong>Registration: </strong>Australian and New Zealand Clinical Trials Registry #12611000318987.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"19 ","pages":"11772719241232870"},"PeriodicalIF":3.8,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10903227/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139997849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"mRNA Expression and Methylation of the <i>RAD51</i>, <i>ATM</i>, <i>ATR</i>, <i>BRCA1</i>, and <i>BRCA2</i> Genes in Gastric Adenocarcinoma.","authors":"Joel Del Bel Pádua, Carolline Fontes Alves Mariano, Alexandre Todorovic Fabro, Fermino Sanches Lizarte Neto, Rogério Lenotti Zuliani, Cláudia Tarcila Gomes Sares, José Sebastião Dos Santos, Ajith Kumar Sankarankutty, Daniela Pretti da Cunha Tirapelli, Vanessa da Silva Silveira, Greice Andreotti de Molfetta, Wilson Araújo da Silva Júnior, Mariângela Ottoboni Brunaldi","doi":"10.1177/11772719231225206","DOIUrl":"10.1177/11772719231225206","url":null,"abstract":"<p><strong>Background: </strong>Immunohistochemical prognostic significance of the homologous recombination-related proteins RAD51, ATM, BRCA1, and BRCA2 is known in gastric adenocarcinoma, one of the deadliest cancers.</p><p><strong>Objective and design: </strong>This retrospective cohort study aimed to evaluate mRNA expression and promoter methylation of some homologous recombination-related genes in this neoplasm.</p><p><strong>Methods: </strong>We evaluated mRNA expression and methylation of <i>RAD51</i>, <i>ATM</i>, <i>ATR</i>, <i>BRCA1</i>, and <i>BRCA2</i> in tumor and non-tumor frozen samples from gastrectomy specimens by RT-qPCR and MS-HRM, correlating our results with previous immunohistochemistry data and prognostic features.</p><p><strong>Results: </strong><i>RAD51</i>, <i>ATR</i>, <i>BRCA1</i>, <i>BRCA2</i>, and <i>ATM</i> mRNA expression was detected in 93.75% (45/48), 93.75% (45/48), 91.67% (44/48), 83.33% (40/48), and 89.58% (43/48) of the tumors; partial or complete methylation, in 94.87% (37/39), 0 (0/42), 97.56% (40/41), 100% (41/41), and 0 (0/40), respectively. Most gene pairs showed significant weak to moderate positive correlations of tumoral mRNA expression with each other: <i>RAD51</i> with <i>ATR</i> (<i>P</i> = .027), <i>BRCA1</i> (<i>P</i> < .001), and <i>BRCA2</i> (<i>P</i> < .001); <i>ATR</i> with <i>BRCA1</i> (<i>P</i> = .007), and <i>ATM</i> (<i>P</i> = .001); <i>BRCA1</i> with <i>BRCA2</i> (<i>P</i> = 0.001). <i>BRCA1</i> mRNA was reduced in tumors compared with non-neoplastic mucosa (0.345 vs 1.272, <i>P</i> = .015) and, excluding neoadjuvant therapy cases, in T3 to T4 tumors compared with T2 (0.414 vs 0.954, <i>P</i> = .035). Greater tumoral <i>RAD51</i> mRNA levels correlated with perineural invasion (1.822 vs 0.725, <i>P</i> = .010) and death (1.664 vs 0.929, <i>P</i> = .036), but not with survival time. There was an inverse association between nuclear immunohistochemical positivity for ATR and its mRNA levels (0.487 vs 0.907, <i>P</i> = .032), and no significant correlation for the other markers.</p><p><strong>Conclusions: </strong>Our results suggest <i>RAD51</i>, <i>BRCA1</i>, and <i>BRCA2</i> methylation as a frequent epigenetic mechanism in gastric cancer, support the hypothesis that reduced <i>BRCA1</i> expression participates in disease progression, and show an association between <i>RAD51</i> mRNA and perineural invasion and mortality that may be considered unexpected, considering the former immunohistochemical studies. The lack of correlation between immunohistochemistry and mRNA, and even the inverse association, for <i>ATR</i>, can be seen as indicative of action of post-transcriptional or post-translational regulatory mechanisms, to be better investigated.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"19 ","pages":"11772719231225206"},"PeriodicalIF":3.4,"publicationDate":"2024-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10826385/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139643125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic Value of Neutrophils-to-Lymphocytes Ratio and Platelets-to-Lymphocytes Ratio in Sepsis Patients With Lymphopenia.","authors":"Xianming Qiu, Quanzhen Wang, Yuke Zhang, Qiannan Zhao, Zhiming Jiang, Lei Zhou","doi":"10.1177/11772719231223156","DOIUrl":"10.1177/11772719231223156","url":null,"abstract":"<p><strong>Background: </strong>Inflammation plays a critical role in sepsis. The integration of neutrophil-to-lymphocyte ratio (NLR) and platelets-to-lymphocytes ratio (PLR) from multiple cell types offers a novel approach to rapidly assess inflammation status. However, the predictive role of NLR and PLR in sepsis with lymphopenia remains uncertain.</p><p><strong>Objectives: </strong>The purpose of this study was to explore the prognostic value of NLR and PLR in sepsis patients with lymphopenia.</p><p><strong>Design and methods: </strong>In this observational retrospective study, we included 172 sepsis patients with lymphopenia and collected clinical characteristics for analysis. Through binary logistic regression analysis, we identified independent factors. Receiver-operating characteristic curves (ROC) and areas under the curves (AUC) were employed to assess the ability to predict hospital mortality risk.</p><p><strong>Results: </strong>Our results showed a total hospital mortality rate of 53.49%. Multivariate analysis demonstrated that NLR (OR = 1.11, <i>P</i> < .001) and PLR (OR = 1.01, <i>P</i> = .003) were independent predictors associated with hospital mortality in sepsis patients with lymphopenia. The AUCs of NLR and PLR were 0.750 (95% CI: 0.634-0.788, <i>P</i> < .001) and 0.662 (95% CI: 0.580-0.743, <i>P</i> < .001), respectively. Notably, an optimal cut-off value of 18.93 for NLR displayed a sensitivity of 75.0% and specificity of 63.0% in discriminating hospital mortality in sepsis patients with lymphopenia, while the optimal cut-off value for PLR was 377.50, with a sensitivity of 67.5% and specificity of 64.1%.</p><p><strong>Conclusion: </strong>NLR and PLR serve as independent predictors of hospital mortality in sepsis patients with lymphopenia.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"19 ","pages":"11772719231223156"},"PeriodicalIF":3.8,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10768602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139378524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of Inflammatory Biomarker suPAR in COVID-19 Disease With CHORUS TRIO Instrument.","authors":"Cerutti Helena, Tesi Giulia, Cartocci Alessandra, Guerranti Roberto, Silvestrini Caterina, Gori Sabrina, Bianciardi Simone, Bandini Tommaso, Brogi Alessandra, Leoncini Roberto","doi":"10.1177/11772719231210407","DOIUrl":"10.1177/11772719231210407","url":null,"abstract":"<p><strong>Background: </strong>Deregulation in the urokinase-type plasminogen activator receptor (uPA/uPAR) system is reported in many diseases where the immune system is activated. During SARS-CoV-2 infection, a rise in soluble uPAR (suPAR) levels has been detected and its concentration above 6 µg/L predicts worsening to severe respiratory failure 14 days earlier, with a positive predictive value of 85.9%, and was the prerequisite for a treatment with anakinra, a recombinant IL-1 receptor antagonist that blocks the activity of both IL-1α and IL-1β.</p><p><strong>Objectives: </strong>To compare suPAR concentrations measured by CHORUS suPAR on CHORUS TRIO instrument of DIESSE with the commercially available suPARnostic (ViroGates) ELISA assay.</p><p><strong>Design: </strong>A single-centre, non-pharmacological, diagnostic study was performed.</p><p><strong>Results: </strong>A total of 522 serum samples from patients with COVID-19 were tested for suPAR. CHORUS suPAR resulted accurate and reliable, with a high grade of specificity (97.9%), accuracy (97.3%) and sensitivity (96.9%). The median concentration of suPAR, as determined with CHORUS suPAR, was 6.8 µg/L (interquartile range 4.5-9.7) in patients with moderate disease (n = 465) and 8.5 µg/L (interquartile range 5.4-10.6) in patients with severe disease. Among patients with moderate and severe disease, 60.6% and 71.9%, respectively, reached the cut-off concentration of suPAR ⩾6 µg/L, defining their illness severity and suggesting eligibility to anakinra treatment.</p><p><strong>Conclusion: </strong>CHORUS suPAR kit resulted as sensitive, specific, accurate and able to quantify suPAR concentrations in patients with moderate and severe COVID-19.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231210407"},"PeriodicalIF":3.8,"publicationDate":"2023-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687937/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138463551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multiomic Approaches for Cancer Biomarker Discovery in Liquid Biopsies: Advances and Challenges.","authors":"Paola Monterroso Diaz,&nbsp;Ashton Leehans,&nbsp;Prashanth Ravishankar,&nbsp;Anna Daily","doi":"10.1177/11772719231204508","DOIUrl":"10.1177/11772719231204508","url":null,"abstract":"<p><p>Cancer is a complex and heterogeneous disease that poses a significant threat to global health. Early diagnosis and treatment are critical for improving patient outcomes, and the use of liquid biopsies has emerged as a promising approach for cancer detection and monitoring. Traditionally, cancer diagnosis has relied on invasive tissue biopsies, the collection of which can prove challenging for patients and the results of which may not always provide accurate results due to tumor heterogeneity. Liquid biopsies have gained increasing attention as they provide a non-invasive and accessible source of cancer biomarkers, which can be used to diagnose cancer, monitor treatment response, and detect relapse. The integration of -omics technologies, such as proteomics, genomics, and metabolomics, has further enhanced the capabilities of liquid biopsies by introducing precision oncology and enabling the tailoring of treatment for individual patients based on their unique tumor biology. In this review, we will discuss the challenges and advances in the field of cancer liquid biopsies and the integration of -omics technologies for different types of liquid biopsies, including blood, tear, urine, sweat, saliva, and cerebrospinal fluid.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231204508"},"PeriodicalIF":3.8,"publicationDate":"2023-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/83/d2/10.1177_11772719231204508.PMC10576933.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41239722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Latest Developments in Using Proteomic Biomarkers from Urine and Serum for Non-Invasive Disease Diagnosis and Prognosis.","authors":"Anurag Shama,&nbsp;Thomson Soni,&nbsp;Ishwerpreet Kaur Jawanda,&nbsp;Garima Upadhyay,&nbsp;Anshika Sharma,&nbsp;Vijay Prabha","doi":"10.1177/11772719231190218","DOIUrl":"https://doi.org/10.1177/11772719231190218","url":null,"abstract":"<p><p>Due to diagnostic improvements, medical diagnostics is demanding non-invasive or minimally invasive methods. Non-invasively obtained body fluids (eg., Urine, serum) can replace cerebral fluid, amniotic fluid, synovial fluid, bronchoalveolar lavage fluid, and others for diagnostic reasons. Many illnesses are induced by perturbations of cellular signaling pathways and associated pathway networks as a result of genetic abnormalities. These disturbances are represented by a shift in the protein composition of the fluids surrounding the tissues and organs that is, tissue interstitial fluid (TIF). These variant proteins may serve as diagnostic \"signatures\" for a variety of disorders. This review provides a concise summary of urine and serum biomarkers that may be used for the diagnosis and prognosis of a variety of disorders, including cancer, brain diseases, kidney diseases, and other system diseases. The studies reviewed in this article suggest that serum and urine biomarkers of various illnesses may be therapeutically useful for future diagnostics. Correct illness management is crucial for disease prognosis, hence non-invasive serum and urine biomarkers have been extensively studied for diagnosis, subclassification, monitoring disease activity, and predicting treatment results and consequences.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231190218"},"PeriodicalIF":3.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1d/f4/10.1177_11772719231190218.PMC10387783.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9916593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Use of Biomarkers in Pharmacovigilance: A Systematic Review of the Literature.","authors":"Maribel Salas,&nbsp;Maxine Gossell-Williams,&nbsp;Priyanka Yalamanchili,&nbsp;Sameer Dhingra,&nbsp;Marina A Malikova,&nbsp;Omar Aimer,&nbsp;Toluwalope Junaid","doi":"10.1177/11772719231164528","DOIUrl":"https://doi.org/10.1177/11772719231164528","url":null,"abstract":"Background The use of biomarkers varies from disease etiognosis and diagnosis to signal detection, risk prediction, and management. Biomarker use has expanded in recent years, however, there are limited reviews on the use of biomarkers in pharmacovigilance and specifically in the monitoring and management of adverse drug reactions (ADRs). Objective The objective of this manuscript is to identify the multiple uses of biomarkers in pharmacovigilance irrespective of the therapeutic area. Design This is a systematic review of the literature. Data Sources and Methods Embase and MEDLINE database searches were conducted for literature published between 2010-March 19, 2021. Scientific articles that described the potential use of biomarkers in pharmacovigilance in sufficient detail were reviewed. Papers that did not fulfill the United States Food and Drug Administration (US FDA) definition of a biomarker were excluded, which is based on the International Conference on Harmonisation (ICH)-E16 guidance. Results Twenty-seven articles were identified for evaluation. Most articles involved predictive biomarkers (41%), followed by safety biomarkers (38%), pharmacodynamic/response biomarkers (14%), and diagnostic biomarkers (7%). Some articles described biomarkers that applied to multiple categories. Conclusion Various categories of biomarkers including safety, predictive, pharmacodynamic/response, and diagnostic biomarkers are being investigated for potential use in pharmacovigilance. The most frequent potential uses of biomarkers in pharmacovigilance in the literature were the prediction of the severity of an ADR, mortality, response, safety, and toxicity. The safety biomarkers identified were used to evaluate patient safety during dose escalation, identify patients who may benefit from further biomarker testing during treatment, and monitor ADRs.","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231164528"},"PeriodicalIF":3.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4b/0e/10.1177_11772719231164528.PMC10108426.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9738493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}