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Clarification on comments re Biomarker

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Need clarification on comments re Biomarker (row 21)

Current Definition

DEFINITION: A measurable and quantifiable biological parameter which serves as index for health- and physiology-related assessments, such as disease risk, psychiatric disorders, environmental exposure and its effects, disease diagnosis, metabolic processes, substance abuse, pregnancy, cell line development, epidemiologic studies, etc. [Source: adapted from MESH]

EXAMPLE(S): Specific enzyme concentration, Specific hormone concentration, Specific gene phenotype distribution in a population, Presence of biological substances

OTHER NAME(S):

NOTE(S):

Ballot Comment

biomarker is currently constrained within the DNA specific context. Therefore, the definition and examples should also be constrained. If desired a note can provide guidance on future intentions.

Current Disposition

Pending Input From Submitter

Proposed Disposition Comment

Need clarification - Is this saying Biomarker in BRIDG is constrained to a DNA-specific context or is it saying that's the case in the CG DAM? The LSDAM Biomarker concept was not necessarily restricted to DNA-specific context. Probably need to get clarification and consult with LSDAM and PGx SMEs to confirm changes.

Outstanding Questions

  • Life Science SMEs: Was the LSDAM concept of Biomarker intended to be constrained to a DNA-specific context?
  • CG SMEs: Is there a Biomarker concept in a CG model that is restricted to a DNA-specific context?
  • Given answers to the above 2 questions, is a change in definition or examples in order?

Responses

Please add your responses here...


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