View source for Discussion on proposed change on MolecularBiomarker Definition

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===Proposed Change on MolecularBiomarker Definition (row 52)===

====Original Definition====

DEFINITION:  An individual mutation that alone or together with other mutations contributes to a medical 

conclusion.

EXAMPLE(S):  L10I, K20R, M36I, A71V, V82T

OTHER NAME(S):  Biological State

NOTE(S):

====Ballot Comment====  
A mutation is only one type of molecular biomarker.  A molecular biomarker does not have to yield a medical-

level conclusion.  This suggestion is similar to the NIH Biomarkers Definitions Working Group definition.

====Proposed Definition====

DEFINITION:  An individual mutation that alone or together with other mutations contributes to a medical 

conclusion.

EXAMPLE(S):  L10I, K20R, M36I, A71V, V82T  <= SHOULD THESE BE CONSISTENT EXAMPLE SCENARIO USED ACROSS ALL 

MOLECULAR BIOLOGY CLASSES???

OTHER NAME(S):  Biological State

NOTE(S):

====Proposed Disposition====  
Persuasive

====Proposed Disposition Comment====  
Review proposed change with PGx SMEs to ensure change is consistent with their original use case for the 

concept.  Also see disposition comments and recommendation on Gene item a few rows above.  Should the two 

definitions be harmonized?

====Outstanding Questions====
* CDISC PGx SMEs:  Is the proposed change consistent with your original use case for MolecularBiomarker?
* Anyone:  Can someone provide a comprehensive, realistic and meaningful set of example values that uses the 

same overall scenario across all classes in the Molecular Biology sub-domain?

====Responses====
Please add your responses here...


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