Mol Diagn Ther
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Acute kidney injury (AKI) represents a common disorder in hospitalized patients, and its incidence is rising at an alarming rate. Despite significant improvements in critical care and renal replacement therapies (RRT), the outcome of critically ill patients with AKI necessitating RRT remains unacceptably dismal. In current clinical practice, the diagnosis and severity classification of AKI is based on a rise in serum creatinine levels, which may occur 2-3 days after the initiating renal insult and delay potentially effective therapies that are limited to the early stage. ⋯ Indiscriminate use of various biomarkers may distract clinicians from adequate clinical evaluation, may result in worse instead of better patient outcomes, and may waste money. Future large randomized studies are necessary to demonstrate the association between biomarker levels and clinical outcomes, such as dialysis, clinical events, or death. It needs to be shown whether assignment to earlier treatment for AKI on the basis of generally accepted biomarker cut-off levels results in a reduction in mortality and an improvement in recovery of renal function.
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Alzheimer disease is the most common cause of dementia, yet its clinical diagnosis remains uncertain until an eventual postmortem histopathology examination. Currently, therapy for patients with Alzheimer disease only treats the symptoms; however, it is anticipated that new disease-modifying drugs will soon become available. Diagnostic tools for detecting Alzheimer disease at an incipient stage that can reliably differentiate the disease from other forms of dementia are of key importance for optimal treatment. ⋯ This includes single protein biomarkers in the cerebrospinal fluid, as well as multi-component biomarkers, and biomarkers based on gene expression. Novel biomarkers that use blood and urine, the more easily available clinical samples, are also being discovered and developed. The plethora of potential biomarkers currently being investigated may soon provide biomarkers that fulfill different functions, not only for diagnostic purposes but also for drug development and to follow disease progression.
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The AmpliChip CYP450 Test, which analyzes patient genotypes for cytochrome P450 (CYP) genes CYP2D6 and CYP2C19, is a major step toward introducing personalized prescribing into the clinical environment. Interest in adverse drug reactions (ADRs), the genetic revolution, and pharmacogenetics have converged with the introduction of this tool, which is anticipated to be the first of a new wave of such tools to follow over the next 5-10 years. The AmpliChip CYP450 Test is based on microarray technology, which combines hybridization in precise locations on a glass microarray and a fluorescent labeling system. ⋯ Assuming more studies are published, pharmacogenetic clinical applications may be compromised by economic factors and the lack of physician education. The combination of a US FDA-approved test, such as the AmpliChip CYP450 Test, and an FDA definition of CYP2D6 as a 'valid biomarker' makes CYP2D6 genotyping a prime candidate to be the first successful pharmacogenetic test in the clinical environment. One can use microarray technology to test for hundreds of single nucleotide polymorphisms (SNPs) but, taking into account the difficulties for single gene approaches such as CYP2D6, it is unlikely that very complex pharmacogenetic approaches will reach the clinical market in the next 5-10 years.