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Molecular Profiling

Overview of attention for book
Cover of 'Molecular Profiling'

Table of Contents

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    Book Overview
  2. Altmetric Badge
    Chapter 1 Tumor staging and grading: a primer.
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    Chapter 2 Clinical trial design in the age of molecular profiling.
  4. Altmetric Badge
    Chapter 3 Personalized medicine: ethics for clinical trials.
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    Chapter 4 Reduction of preanalytical variability in specimen procurement for molecular profiling.
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    Chapter 5 The human side of cancer biobanking.
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    Chapter 6 Introduction to genomics.
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    Chapter 7 Genomic profiling: cDNA arrays and oligoarrays.
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    Chapter 8 Genome-wide methylation profiling in archival formalin-fixed paraffin-embedded tissue samples.
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    Chapter 9 An Overview of MicroRNA Methods: Expression Profiling and Target Identification.
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    Chapter 10 Antibody Validation by Western Blotting
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    Chapter 11 Laser Capture Microdissection: Arcturus(XT) Infrared Capture and UV Cutting Methods.
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    Chapter 12 Antibody microarrays: analysis of cystic fibrosis.
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    Chapter 13 Tissue microarrays as a tool in the discovery and validation of predictive biomarkers.
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    Chapter 14 Reverse-phase protein microarrays.
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    Chapter 15 Serum low-molecular-weight protein fractionation for biomarker discovery.
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    Chapter 16 Mass spectrometry-based biomarker discovery.
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    Chapter 17 Mitochondrial proteome: toward the detection and profiling of disease associated alterations.
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    Chapter 18 Adult neural stem cells: isolation and propagation.
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    Chapter 19 Evanescent-wave field imaging: an introduction to total internal reflection fluorescence microscopy.
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    Chapter 20 Construction and hyperspectral imaging of quantum dot lysate arrays.
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    Chapter 21 Microarray data analysis: comparing two population means.
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    Chapter 22 Bioinformatics/Biostatistics: microarray analysis.
  24. Altmetric Badge
    Chapter 23 Structure-based functional design of drugs: from target to lead compound.
  25. Altmetric Badge
    Chapter 24 Personalized medicine: changing the paradigm of drug development.
  26. Altmetric Badge
    Chapter 25 Grant writing tips for translational research.
  27. Altmetric Badge
    Chapter 26 Inventions and patents: a practical tutorial.
  28. Altmetric Badge
    Chapter 27 Regulatory approval pathways for molecular diagnostic technology.
  29. Altmetric Badge
    Chapter 28 Small business development for molecular diagnostics.
Attention for Chapter 27: Regulatory approval pathways for molecular diagnostic technology.
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Chapter title
Regulatory approval pathways for molecular diagnostic technology.
Chapter number 27
Book title
Molecular Profiling
Published in
Methods in molecular biology, October 2011
DOI 10.1007/978-1-60327-216-2_27
Pubmed ID
Book ISBNs
978-1-60327-215-5, 978-1-60327-216-2
Authors

Lance A. Liotta, Emanuel F. Petricoin III, Emanuel F. Petricoin

Editors

Virginia Espina, Lance A. Liotta

Abstract

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 obtaining Food and Drug Administration (FDA) approval of an IVD: (a) If the new test can be shown to be substantially equivalent to an existing predicate test on the market, then the 510(k) is the regulatory path for new device approval. (b) If your new diagnostic technology cannot be considered substantially equivalent to an existing technology, and will be used to make a critical medical decision concerning the diagnosis, treatment, or medical management, then the premarket approval (PMA) is the regulatory path of choice. (c) If no predicate device exists and the test is of low or moderate risk, it may be eligible for a de novo reclassification. If the test is done "in house," in the designated laboratory only, for a patient sample that is sent to the laboratory from an outside physician's office or medical facility, then the test can be potentially marketed under "home brew" guidelines (also known as laboratory developed tests) regulated under the Clinical Laboratory Improvement Amendments (CLIA). The Centers for Medicare and Medicaid Services (CMS) assumes primary responsibility for financial management operations of the CLIA program, but the categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. Definitions, guidelines, information sources, and instructions for data requirements are outlined for each regulatory pathway.

Twitter Demographics

The data shown below were collected from the profile of 1 tweeter who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 20 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 20 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 6 30%
Other 4 20%
Student > Ph. D. Student 4 20%
Student > Bachelor 2 10%
Student > Master 2 10%
Other 2 10%
Readers by discipline Count As %
Agricultural and Biological Sciences 8 40%
Biochemistry, Genetics and Molecular Biology 4 20%
Medicine and Dentistry 4 20%
Social Sciences 1 5%
Psychology 1 5%
Other 0 0%
Unknown 2 10%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 29 April 2012.
All research outputs
#9,680,064
of 12,105,416 outputs
Outputs from Methods in molecular biology
#4,161
of 8,293 outputs
Outputs of similar age
#79,402
of 105,437 outputs
Outputs of similar age from Methods in molecular biology
#16
of 45 outputs
Altmetric has tracked 12,105,416 research outputs across all sources so far. This one is in the 11th percentile – i.e., 11% of other outputs scored the same or lower than it.
So far Altmetric has tracked 8,293 research outputs from this source. They receive a mean Attention Score of 2.0. This one is in the 32nd percentile – i.e., 32% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 105,437 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 12th percentile – i.e., 12% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 45 others from the same source and published within six weeks on either side of this one. This one is in the 31st percentile – i.e., 31% of its contemporaries scored the same or lower than it.