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Related Concept Videos

What is Gene Expression?01:42

What is Gene Expression?

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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...
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Regulation of Expression Occurs at Multiple Steps02:24

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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.
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Regulation of Expression at Multiple Steps01:23

Regulation of Expression at Multiple Steps

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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...
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Cell Specific Gene Expression01:58

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Reporter Genes02:11

Reporter Genes

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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.
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Structure of a Gene01:30

Structure of a Gene

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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...
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Regulatory Perspectives for Gene Expression-Based Diagnostic Devices.

Lakshman Ramamurthy1,2

  • 1Regulatory Affairs, GRAIL, LLC, Washington, DC, USA. lramamurthy@grailbio.com.

Methods in Molecular Biology (Clifton, N.J.)
|February 3, 2025
PubMed
Summary
This summary is machine-generated.

Genomic diagnostic technologies offer insights into gene dysregulation and disease, driving regulatory updates from the US Food and Drug Administration for innovator and regulator guidance.

Keywords:
Analytical validityCLIAClinical validityFDALaboratory-developed tests (LDTs)Medical device regulationReal-world dataSpecificitypremarket approval

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Area of Science:

  • Genomic science and molecular diagnostics.

Background:

  • Genomic methods analyze gene dysregulation, including epigenetic changes and gene expression, impacting human health and disease.
  • These accessible technologies are standard in oncology and other diseases, enabling predictive claims for treatment response and early disease screening.

Purpose of the Study:

  • To describe the regulation of genomic diagnostic technologies.
  • To provide guidance for both innovators and regulators in the evolving landscape of molecular diagnostics.

Main Methods:

  • Review of genomic technologies and their applications in health and disease.
  • Analysis of the regulatory landscape for molecular diagnostics, particularly concerning the US Food and Drug Administration's efforts.

Main Results:

  • Genomic technologies have expanded, leading to increased use in predictive diagnostics and disease screening.
  • This expansion necessitates updated regulatory frameworks by agencies like the US Food and Drug Administration.

Conclusions:

  • The regulation of genomic diagnostic technologies is crucial for their safe and effective implementation.
  • Understanding these regulations is vital for innovators developing new genomic tests and for regulators overseeing their approval and use.