Biomarkers in medicine
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Biomarkers in medicine · Feb 2019
ReviewMeasurement of pancreatic stone protein in the identification and management of sepsis.
Sepsis is a life-threatening syndrome characterized by a dysregulated host response to an infection resulting in multiple organ dysfunctions. Early diagnosis and management of sepsis is key to improve patient outcome but remains challenging. ⋯ Several lines of evidences suggest that PSP has a higher diagnostic performance for the identification of sepsis than procalcitonin and C-reactive protein, and a strong prognostic value to predict unfavorable outcome at admission to intensive care unit. This review summarizes the current knowledge on the molecular mechanisms of PSP function and the clinical evidences available to highlight the relevance of this protein in the diagnosis and prognosis of sepsis.
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Biomarkers in medicine · Aug 2018
ReviewPredictive biomarkers of chemotherapy-induced peripheral neuropathy: a review.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of taxane treatment during chemotherapy. Identifying predictive biomarkers of CIPN would allow physicians to alter treatment given to patients according to a personal risk of developing this condition. ⋯ Possible mechanisms underlying the relationship between these single nucleotide polymorphisms and CIPN development are explored. The biomarkers identified in this study should be investigated further to generate predictive biomarkers that may be used in a clinical setting.
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The field of immuno-oncology has witnessed unprecedented success in recent years, with several PD=1 and PD-L1 inhibitors obtaining US FDA registration and breakthrough drug therapy designation in multiple tumor types. Despite its clear efficacy in certain cancers, treatment with these agents carries a risk of immune-related toxicities and substantial financial burden. ⋯ We first examine the role of PD-L1 expression, the most extensively studied predictive biomarker of response, and further discuss emerging putative predictive biomarkers. We also detail challenges faced in the development of response assessments for immunotherapeutics and propose other biomarkers that may be useful as surrogate intermediate end points of response.
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Biomarkers in medicine · Aug 2016
ReviewPlatelet function testing as a biomarker for efficacy of antiplatelet drugs.
Despite the overwhelming evidence in support of the efficacy of dual antiplatelet therapy with aspirin and clopidogrel, it is also obvious that not all patients benefit from these drugs to the same extent. This interindividual variability in platelet responses may underlie clinical differences in drug efficacy, with potential for optimization of antiplatelet therapy to prevent ischemic events without excessively increasing bleeding risk. This review presents the current evidence regarding platelet function testing for monitoring of antiplatelet therapy, with emphasis on the prognostic value of platelet function testing to predict ischemic and bleeding events. The potential of platelet function testing to provide personalized antiplatelet therapy is also discussed, with an outlook toward the future of platelet function testing in high-risk individuals.
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Biomarkers in medicine · Jan 2015
ReviewRegulatory considerations for companion diagnostic devices.
The emergence of companion diagnostic devices has been spurred by drug discovery and development efforts towards targeted therapies, particularly in oncology. Companion diagnostics and their corresponding therapeutics are often codeveloped, or developed in parallel, to ensure the safe and effective use of the products. ⋯ Here, we describe the current regulatory model for companion diagnostics in the US and outline key strategies for a successful codevelopment program from the device perspective. We also discuss how technological advances and changes in clinical management may challenge the regulatory model in the future.