Biomarkers in medicine
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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.
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Biomarkers in medicine · Jan 2015
Developing retinal biomarkers of neurological disease: an analytical perspective.
The inaccessibility of the brain poses a problem for neuroscience. Scientists have traditionally responded by developing biomarkers for brain physiology and disease. ⋯ However, new analytical methods are needed to show whether or not retinal signs really are equivalent to brain abnormalities, since this requires greater evidence than direct associations between retina and brain. We, therefore propose a new way to think about, and test, how clearly one might see the brain through the retinal window, using cerebral malaria as a case study.
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Biomarkers in medicine · Jan 2015
The prognostic performance of the complement system in septic patients in emergency department: a cohort study.
To investigate the prognostic performance of complement components in septic patients, complement 3, membrane attack complex (MAC) and mannose-binding lectin were measured and compared among adult patients with sepsis, severe sepsis and septic shock, as well as between in-hospital nonsurvivors and survivors. ⋯ MEDS and MAC independently predicted in-hospital mortality. The prognostic performance of MAC was superior to MEDS as analyzed by receiver operating characteristic curve and area under the curve.
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Biomarkers in medicine · Jan 2014
ReviewWhat can we expect from biomarkers for acute kidney injury?
Biomarkers for acute kidney injury have numerous potential roles to play both at the bedside and in the design and conduct of clinical trials. Given the heterogeneous nature of this disease and the difficulty, so far, in developing effective therapies, a strategy that deploys all of our available tools in the treatment and in study of treatments would seem prudent. In this review, we discuss how biomarkers will change the way we do we take care of patients with and do clinical trials in acute kidney injury and why, in fact, biomarkers are necessary.