Bicarbonate serves many functions in our body. It is the predominant buffer maintaining a physiological pH in the blood and within our cells. It is also essential for proper digestion of nutrients and solubilization of complex protein mixtures, such as digestive enzymes and mucins, in epithe ...
MicroRNAs (miRNAs) are small, single-stranded RNA molecules encoded by genes that are transcribed from DNA but not translated into protein (noncoding RNA). The ability of miRNA to regulate the expression of, as yet, an unknown quantity of targets has recently become an area of huge interest to re ...
New technologies allow for genome-scale measurement of DNA methylation. In an effort to increase the clinical utility of DNA methylation as a biomarker, we have adapted a commercial bisulfite epigenotyping assay for genome-wide methylation profiling in archival formalin-fixed p ...
The introduction of microarray technology, which is a multiplexed hybridization-based process, allows simultaneous analysis of a large number of nucleic acid transcripts. This massively parallel analysis of a cellular genome will become essential for guiding disease diagnos ...
The Science of Genomes: Only within the past few decades have scientists progressed from the analysis of a single or a small number of genes at once to the investigation of thousands of genes, going from the study of the units of inheritance to the investigation of the whole genome of an organism. The science ...
The future success of translational research is critically dependent on the procurement and availability of high-quality tissue specimens linked to accurate histopathologic and clinical information about the individual banked specimen. The international community has a ...
Despite the tremendous perceived value, and the predicted high abundance, of disease-associated tissue biomarkers, the number of biomarkers that have been validated for routine clinical use is very low. The major roadblock has been the sample-to-sample variability and perishabil ...
Modern ethical codes in medicine were developed following World War II to provide respect for persons, beneficence, and justice in clinical research. Clinical trial medicine involves greater scrutiny than most research activities. In every instance, clinical trials have institu ...
The accelerating science of molecular profiling has necessitated a rapid evolution in clinical trial design. Traditional clinical research begins with Phase I studies to characterize dose-limiting toxicities and defines maximally tolerated doses of drugs in small numbers of pa ...
Molecular profiling, which is the application of molecular diagnostics technology to tissue and blood �specimens, is an integral element in the new era of molecular medicine and individualized therapy. Molecular diagnostics is a fertile ground for small business development beca ...
This chapter describes the basic categories for regulatory approval to sell/market a molecular profiling technology. The US Food and Drug Administration regulates and provides guidance, for marketing in vitro diagnostic devices (IVD). Three different paths currently exist for o ...
Patents are designed to protect and encourage creativity and innovation. Patenting a biomedical discovery can be a requirement before a pharmaceutical company or biotech entity will invest in the lengthy and costly clinical testing necessary to achieve patient benefit. Although sc ...
All investigators face the same challenge – the highly competitive nature of the grant review process. Innovation alone is not enough to ensure grant supported funding. Applied clinical research requires a diverse collaborative team of investigators with specialized skills, a supp ...
Despite an increased investment in research and development, there has been a steady decline in the number of drugs brought to market over the past 40 years. The tools of personalized medicine are refining diseases into molecular categories, and future therapeutics may be dictated by a patient ...
Proteomic and genomic discoveries have identified vast numbers of new drug targets for investigation. In the quest to discover drugs that modulate the function of these targets, identification of small-molecule drug leads is one of the earliest steps. Structure-based drug design has em ...
The quantity and complexity of the molecular-level data generated in both research and clinical settings require the use of sophisticated, powerful computational interpretation techniques. It is for this reason that bioinformatic analysis of complex molecular profiling data ...
Scientists employing microarray profiling technology to compare sample sets generate data for a large number of endpoints. Assuming the experimental design minimized sources of bias, and the analytical technology was reliable, precise, and accurate, how does the experimentali ...
The emerging field of proteomic molecular profiling will be driven by new technologies that can measure dozens to hundreds of proteins from a small sample input from a patient’s biopsy. Lysate arrays, or reverse-phase protein microarrays, provide a platform for complex mixtures of protei ...
Cancer staging and grading are used to predict the clinical behavior of malignancies, establish appropriate therapies, and facilitate exchange of precise information between clinicians. The internationally accepted criteria for cancer staging, the tumor-node-metastas ...
Advancements in technology and computational power in recent years have directly impacted modern microscopy through improvements in light detection, imaging software platforms, as well as integration of complex hardware systems. These successes have allowed for mainstream ...
