Clarification on comments re Biomarker

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CLOSED - 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

Lauren Becnel: LS DAM should not have been limited even to molecules per se. For example, grey hair is a biomarker for aging. The comment from the ballot may have been in reference to the CG WG. The question is one of scope because as I’ve already commented clin genomics are not the only ‘omics-based test types that are used within the clinic and resulting from translated research.

(NO CHANGE NEEDED)

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