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Companion diagnostic testing topic template

Revised: 5 August 2020
Copyright: 2019-2020, PathologyOutlines.com, Inc.

    For ease of use, we put topic headings in the same order. Please put some text under each heading, but do not include obvious or repetitive information. If you think there is nothing to add, please write "not relevant to this topic", "repetitive with __ heading" or "unknown at this time" [i.e. if etiology is not known]. Do not delete any topic headings.


    Author 1

    Author name with degrees: ___________________________________________

    Author rank (M.D. candidate / Resident / Fellow / Instructor / Assistant, Associate or Full Professor): ___________________________________________

    Author leadership roles (maximum of 2) (ex: Director of Surgical Pathology, Vice Chair of Anatomic Pathology, Director of Cytopathology): ___________________________________________

    Author institution name: ___________________________________________

    Author institution city, state, zip code and country: ___________________________________________

    Author email address: ___________________________________________


    Author 2

    Author name with degrees: ___________________________________________

    Author rank (Assistant, Associate or Full Professor): ___________________________________________

    Author leadership roles (maximum of 2) (ex: Director of Surgical Pathology, Vice Chair of Anatomic Pathology, Director of Cytopathology): ___________________________________________

    Author institution name: ___________________________________________

    Author institution city, state, zip code and country: ___________________________________________

    Author email address: ___________________________________________



    Chapter name: Companion diagnostic testing

    Section and subsection (in the Table of Contents): ___________________________________________

    Topic name:___________________________________________


    Note: These topics should discuss one diagnostic entity with its own companion diagnostic testing protocol and treatment. Contact us if you want to combine diagnostic entities at the same site.


    Definition / general
    A 1 - 2 sentence summary of the topic.

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    Essential features
    This topic heading should be completed after the rest of the topic is finished, and should duplicate the 3 - 5 most important points mentioned elsewhere in the topic. In other words, it should list what every pathologist should know about the topic or what would be in a Board Review book.

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    Sites
    Parts of the body or organ discussed in this topic.

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    Pathophysiology
    Step by step details of the biomarkers discussed in this topic in relationship to the tumor.

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    Diagrams
    Those that don't automatically fit in another section. Provide caption and figure legend.


    Clinical information
    Anything clinical not included above or below. Includes associations with other conditions.

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    Diagnosis
    Diagnostic criteria for the entities discussed needed to use the companion diagnostics.

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    Uses by pathologists
    How are these results typically used by practicing pathologists?

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    Prognostic factors
    Favorable or unfavorable prognostic factors for a condition based on the biomarkers discussed. Overall prognosis, recurrence rates, etc.

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    Case reports
    List at least 2 quality case reports, preferably from the past 5 years (unless the diagnosis is exceedingly rare). The format should be written as "25 year old man with large retroperitoneal mass (PMID: XXXX)." We prefer case reports from free full text PubMed archived journals in English. To find case reports that meet this criteria, use the following PubMed search (fill in the diagnosis): DIAGNOSIS case reports[PT] free full text[SB] 2015:2020[DP] english[LA]. This search should also be utilized to find images that you are not able to provide, such as molecular / cytogenetics.

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    Treatment
    Treatments related to the biomarker testing. Link to drugs listed in this chapter, if relevant. Include general drug name and trade name, its mode of action, clinical information of interest to pathologists (FDA approval date, if any; recommended uses; links to FDA companion diagnostic test guides, estimated monthly cost, side effects). Drug dosages are not necessary - if you want to include them, please provide a reference.

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    Positive stains
    Include any information about IHC and special stains not listed above, including staining patterns and testing thresholds.

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    Negative stains
    Include any information about IHC and special stains not listed above, including staining patterns and testing thresholds.

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    Molecular / cytogenetics description
    Description of DNA / RNA findings not discussed above based on testing via sequencing, PCR, FISH, CISH, ISH, cytogenetics, etc.

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    Molecular / cytogenetics images
    Images of FISH, CISH, ISH, electropherograms, PCR gels, karyograms, etc. For images you submit, provide a brief 1 - 4 word caption to appear below the thumbnail of the image and a longer figure legend to appear when the image is opened. If you do not have your own images, refer to the Case reports section for how to provide links to journal images, and provide links with a brief 1 - 4 word caption.


    Videos
    Links to YouTube or other sites or create your own (preferably 5 minutes or less). Provide a caption for each video. Dr. Gardner has many skin and soft tissue videos on his YouTube page.


    Sample pathology report
    Provide an example of a typical test results report for the biomarker. Include all information that would be in a report, including thresholds, testing conditions and disclaimers.

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    Additional references
    General references for this topic not included above.

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    Board Review Question(s)
    Prepare 2 board review style questions that highlight important content from this topic. These are not actual questions from the Pathology boards but review questions written in a similar format. The questions should test basic, essential diagnostic concepts that all pathologists should know rather than minor details. The topic needs to contain all information relevant to correct and incorrect answers. Questions should be multiple choice, such as "Which of the following is true about XXX tumor/disease?" Do not use the format "Which of the following is false?" Questions should have only one answer. Do not use responses "all of the above", "none of the above", "A and C", etc. This question will be part of our Board Review page so the reader will not know the topic with which it is associated. Therefore you must make the organ clear in the question and the diagnosis clear in the answer. Click here for examples.


    Board Review Answer(s)
    Answers to the Question(s) above, sorted alphabetically by the first letter in the answer.