基于基因表达的诊断设备的监管前景
1Regulatory Affairs, GRAIL, LLC, Washington, DC, USA. lramamurthy@grailbio.com.
Methods in molecular biology (Clifton, N.J.)
|February 3, 2025
概括
基因组诊断技术为基因失调和疾病提供了洞察力,推动美国食品和药物管理局的监管更新,以提供创新者和监管机构的指导.
科学领域:
- 基因组科学和分子诊断.
背景情况:
- 基因组方法分析基因失调,包括表观遗传变化和基因表达,影响人类健康和疾病.
- 这些可访问的技术是瘤学和其他疾病的标准,使得治疗反应和早期疾病查的预测性要求成为可能.
研究的目的:
- 描述基因组诊断技术的监管.
- 为创新者和监管机构在不断变化的分子诊断领域提供指导.
主要方法:
- 审查基因组技术及其在健康和疾病中的应用.
- 分析分子诊断的监管环境,特别是美国食品和药物管理局的努力.
主要成果:
- 基因组技术已经扩展,导致预测诊断和疾病查的使用增加.
- 这种扩张需要美国食品和药物管理局等机构更新监管框架.
结论:
- 对基因组诊断技术的监管对于其安全有效的实施至关重要.
- 了解这些法规对于开发新基因组测试的创新者以及监管机构监督其批准和使用至关重要.
相关概念视频
What is Gene Expression?
166.8K
Overview
Gene expression is the process in which DNA directs the synthesis of functional products, that is, proteins. Cells can regulate gene expression at various stages. It allows organisms to generate different cell types and enables cells to adapt to internal and external factors.
Genetic Information Flows from DNA to RNA to Protein
A gene is a stretch of DNA that serves as the blueprint for functional RNAs and proteins. Since DNA is made up of nucleotides and proteins consist of amino...
Gene expression is the process in which DNA directs the synthesis of functional products, that is, proteins. Cells can regulate gene expression at various stages. It allows organisms to generate different cell types and enables cells to adapt to internal and external factors.
Genetic Information Flows from DNA to RNA to Protein
A gene is a stretch of DNA that serves as the blueprint for functional RNAs and proteins. Since DNA is made up of nucleotides and proteins consist of amino...
166.8K
Regulation of Expression Occurs at Multiple Steps
22.4K
Gene expression can be regulated at almost every step from gene to protein. Transcription is the step that is most commonly regulated. This involves the binding of proteins to short regulatory sequences on the DNA. This association can either promote or inhibit the transcription of a gene associated with the respective sequence.
Transcription results in the generation of precursor (pre-mRNA) that consists of both exons and introns, which needs further processing before being translated to a...
Transcription results in the generation of precursor (pre-mRNA) that consists of both exons and introns, which needs further processing before being translated to a...
22.4K
Regulation of Expression at Multiple Steps
864
The gene expression in cells is regulated at different stages: (i) transcription, (ii) RNA processing, (iii) RNA localization, and (iv) translation. Transcriptional regulation is mediated by regulatory proteins such as transcription factors, activators, or repressors—these control gene expression by initiating or inhibiting the transcription of genes. Once a precursor or pre-mRNA is produced, it undergoes post-transcriptional modification, including 5' capping, splicing, and the...
864
Cell Specific Gene Expression
4.6K
4.6K
Reporter Genes
11.2K
Reporter genes are a type of protein-coding gene that are often tagged to a gene of interest. Once inside a target cell, reporter genes usually produce visually identifiable characteristics like fluorescence and luminescence when expressed along with the gene of interest. Thus, reporter genes “report” the presence or absence of genes of interest in an organism, determine the gene expression pattern, or track the physical location of a DNA segment or protein in the cell.
11.2K
Structure of a Gene
12.4K
A gene is the fundamental unit of heredity. Every individual has two copies of each gene, one inherited from each parent. Although most people contain the same genes, there is a small fraction that is slightly different amongst people. A gene with a small difference in its sequence of DNA bases forms different alleles, contributing to different phenotypes.
However, only 1% of the DNA is composed of genes that encode proteins; the rest, 99% is non-coding DNA. This non-coding DNA performs...
However, only 1% of the DNA is composed of genes that encode proteins; the rest, 99% is non-coding DNA. This non-coding DNA performs...
12.4K


