A Review of the Growth Opportunities and Challenges That Are Being Faced by Clinical Genomics.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c31841) has announced the addition of The Impact of Genomics on Clinical Trials to their offering. The Impact of Genomics on Clinical Trials and Medical Practice evaluates the potential of clinical genomics to transform drug development and the practice of medicine. The report projects significant growth opportunities in this field, balanced with a realistic assessment of the challenges and hurdles to bringing clinical genomics to mainstream medicine. Clinical genomics is the application of large-scale, high-throughput genomics technologies in clinical settings, such as clinical trials or primary care of patients. Clinical genomics promises to allow a molecular understanding of disease and drug response, with benefits in all areas of medicine. Contributing to the growth of genomics, in 2005 the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. issued guidelines for applications of genomics in drug development, with the stated hope that genomics will improve the safety and effectiveness of medicines. Given this mandate, clinical genomics applications appear to have crossed a threshold with the recent approval of several clinical genomics products. These approvals are expected to provide important precedents for other product approvals in the near future. Examples reviewed in the report include the following: --Affymetrix's AmpliChip Cytochrome cytochrome (sī`təkrōm'), protein containing heme (see coenzyme) that participates in the phase of biochemical respiration called oxidative phosphorylation. P450 Genotyping Test: In 2004 this test, a DNA chip DNA chip See DNA microarray. Noun 1. DNA chip - a microchip that holds DNA probes that form half of the DNA double helix and can recognize DNA from samples being tested gene chip that identifies variations in two genes affecting response to a wide variety of drugs, became the first microarray approved for treatment decisions by the FDA. --Third Wave Technologies' Invader UGT UGT abbr. urgent (telegram) 1A1 Test: This test for detecting heightened risk of adverse reaction to the chemotherapy drug irinotecan was FDA-approved in 2005 as the first pharmacogenetic companion diagnostic paired with a specific drug therapy. Genomics applications in clinical trials are also dramatically rising. It is now estimated that about 20% of U.S. clinical trials use some sort of genomics approach, with the highest percentage in oncology trials. While this trend is expected to accelerate during the next few years, the Years, The the seven decades of Eleanor Pargiter’s life. [Br. Lit.: Benét, 1109] See : Time field still faces considerable regulatory, technical, economic, and sociological hurdles. The full promise of clinical genomics applications may not be fully realized for at least another ten to fifteen years. However, as genomics transitions away from primarily research to more clinical applications, the field will be ripe with business opportunities and the report examines some of the business and strategic factors relevant to the further adoption of genomics technologies in clinical trials and medical practice. Topics Covered Chapter 1. Introduction 1.1. Overview 1.2. The Impact of Genomics in the Clinic 1.3. Impact of Data from the Human Genome The human genome is the genome of Homo sapiens, which is composed of 24 distinct pairs of chromosomes (22 autosomal + X + Y) with a total of approximately 3 billion DNA base pairs containing an estimated 20,000–25,000 genes. 1.4. The Promise of Clinical Genomics 1.5. Challenges in the Field Chapter 2. Applications of Genomics in Clinical Trials and Medicine 2.1. Prediction, Detection, and Diagnosis of Disease 2.2. Predicting Response to Drugs 2.3. Factors Influencing Response to Drugs 2.4. Personalized Medicine  The external links in this article or section may require cleanup to comply with Wikipedia's content policies. 2.5. Toxicogenomics 2.6. Determining Risk of Disease 2.7. Gene Therapy 2.8. Identifying Individuals 2.9. Proteomics Chapter 3. Genomic Technologies for the Clinic 3.1. Overview 3.2. Detecting DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. Variation 3.3. SNP SNP Scottish National Party Noun 1. SNP - (genetics) genetic variation in a DNA sequence that occurs when a single nucleotide in a genome is altered; SNPs are usually considered to be point mutations that have been evolutionarily Genotyping Methods 3.4. Gene Expression Detection 3.5. RNA Interference RNA interference n. A process in which the introduction of double-stranded RNA into a cell inhibits the expression of genes. 3.6. Other Technologies Chapter 4. Advances in Clinical Genomics Applications 4.1. Overview 4.2. Toxicogenomics 4.3. Clinical Trials 4.4. Clinical Oncology 4.5. Infectious Diseases 4.6. Newborn Screening newborn screening Neonatology The analysis of a neonate's blood for metabolic or other disorders to prevent mental retardation, disability or death 4.7. Genomics and Race 4.8. Genomics and Drug Labeling Chapter 5. Business and Strategic Factors 5.1. Overview 5.2. Patient Stratification 5.3. Scientific Issues 5.4. Standardization and Quality Control 5.5. Physician and Payer Response 5.6. Drug-Diagnostic Codevelopment: Theranostics 5.7. The Regulatory Environment 5.8. Cost-Benefit Analysis cost-benefit analysis In governmental planning and budgeting, the attempt to measure the social benefits of a proposed project in monetary terms and compare them with its costs. 5.9. Niche Markets for Clinical Genomics References Index List of Tables and Figures For more information visit http://www.researchandmarkets.com/reports/c31841 |
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