Comment:

biomarker handling comment http://hl7.org/fhir/us/mcode/2019SEP/StructureDefinition-onco-core-TumorMarkerTest.html applaud the attempt. A valueset of LOINC codes helps the implementor. However, would consider consulting with BRIDGE on the way to express a biomarker computably, if the goal is to use the profile outside the context of oncology reporting. The valueset will need a steward and should be accessible, consider VSAC depending on use case. If the profile is not proprietary and is meant to be used in regulated reporting then VSAC would be highly appropriate. Again, there is a maintence cost to using precoordinated terminology to provide identification of the biomarker. Is there a biomarker naming authority in oncology? Would incorporating the GENE name or a reference to variantTested be useful. It is a big ask to create a robust universal biomarker profile. I can see why you would use the value set. However, the name of the biomarker, associated gene if one exists, etc... are descriptive fields that can allow for post-coordination. I do not know how much to press here. The use case is oncology reporting to tumor registries, this is secondary to clinical practice so having to use a valueset and needing to write logic to determine if the biomarker is a protein or substance may not be a major issue for implementors of clinical research systems. The problem arises when we have a genomic variant test that could be used as a biomarker finding or more discretely. Good luck

Summary:

Consider postcoordination of biomarker and associated gene (if one exists)