Genomics Reporting Implementation Guide
2.0.0 - trial-use

This page is part of the Genetic Reporting Implementation Guide (v2.0.0: STU 2) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

: TxImp02 - XML Representation

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<Observation xmlns="http://hl7.org/fhir">
  <id value="TxImp02"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/therapeutic-implication"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">Poor metabolizer of Voriconazole</div>
  </text>
  <extension
             url="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/genomics-artifact">
    <valueRelatedArtifact>
      <type value="citation"/>
      <url
           value="https://cpicpgx.org/guidelines/guideline-for-voriconazole-and-cyp2c19/"/>
    </valueRelatedArtifact>
  </extension>
  <status value="final"/>
  <category>
    <coding>
      <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
      <code value="laboratory"/>
    </coding>
  </category>
  <code>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
      <code value="therapeutic-implication"/>
    </coding>
  </code>
  <derivedFrom>
    <reference value="Observation/Pgx-geno-1001"/>
  </derivedFrom>
  <component>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="51963-7"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://ncimeta.nci.nih.gov"/>
        <code value="C0393080"/>
        <display value="voriconazole"/>
      </coding>
    </valueCodeableConcept>
  </component>
  <component>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
        <code value="predicted-therapeutic-implication"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://loinc.org"/>
        <code value="LA9657-3"/>
        <display value="Poor metabolizer"/>
      </coding>
    </valueCodeableConcept>
  </component>
  <component>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
        <code value="conclusion-string"/>
      </coding>
    </code>
    <valueString
                 value="For voriconazole, higher dose-adjusted trough concentrations of voriconazole are expected in individuals with this genotype and may increase the probability of adverse events. An alternative agent that is not dependent on CYP2C19 metabolism such as isavuconazole, liposomal amphotericin B, or posaconazole is recommended as primary therapy in lieu of voriconazole. A lower than standard dosage of voriconazole with careful therapeutic drug monitoring is another alternative. Refer to current guidelines for dosage and recommendations at https://cpicpgx.org/guidelines/guideline-for-voriconazole-and-cyp2c19/."/>
  </component>
</Observation>