public override FinalizeTestResult Finish(AccessionOrder accessionOrder)
{
HER2AnalysisSummary.HER2AnalysisSummaryTest test = new HER2AnalysisSummary.HER2AnalysisSummaryTest();
HER2AnalysisSummary.HER2AnalysisSummaryTestOrder testOrder = (HER2AnalysisSummary.HER2AnalysisSummaryTestOrder)accessionOrder.PanelSetOrderCollection.GetPanelSetOrder(test.PanelSetId, this.m_OrderedOnId, true);
testOrder.SetValues(accessionOrder);
return(base.Finish(accessionOrder));
}
public HER2AmplificationResult(PanelSetOrderCollection panelSetOrderCollection, HER2AnalysisSummary.HER2AnalysisSummaryTestOrder panelSetOrder)
{
Her2AmplificationByIHC.Her2AmplificationByIHCTest her2AmplificationByIHCTest = new Her2AmplificationByIHC.Her2AmplificationByIHCTest();
HER2AmplificationRecount.HER2AmplificationRecountTest her2AmplificationRecountTest = new HER2AmplificationRecount.HER2AmplificationRecountTest();
this.m_HER2AnalysisSummaryTestOrder = panelSetOrder;
this.m_Indicator = this.m_HER2AnalysisSummaryTestOrder.Indicator;
this.m_AverageHer2Chr17SignalAsDouble = this.m_HER2AnalysisSummaryTestOrder.AverageHer2Chr17SignalAsDouble;
this.m_AverageHer2NeuSignal = this.m_HER2AnalysisSummaryTestOrder.AverageHer2NeuSignal;
this.m_IsHer2AmplificationByIHCRequired = true;
if (panelSetOrderCollection.Exists(her2AmplificationByIHCTest.PanelSetId) == true)
{
this.m_IsHer2AmplificationByIHCOrdered = true;
this.m_PanelSetOrderHer2AmplificationByIHC = (Her2AmplificationByIHC.PanelSetOrderHer2AmplificationByIHC)panelSetOrderCollection.GetPanelSetOrder(her2AmplificationByIHCTest.PanelSetId);
if (this.m_PanelSetOrderHer2AmplificationByIHC.Final == true)
{
if (this.m_PanelSetOrderHer2AmplificationByIHC.Score == "2+")
{
this.m_IsHER2AmplificationRecountRequired = true;
}
}
}
if (panelSetOrderCollection.Exists(her2AmplificationRecountTest.PanelSetId) == true)
{
this.m_IsHER2AmplificationRecountOrdered = true;
this.m_HER2AmplificationRecountTestOrder = (HER2AmplificationRecount.HER2AmplificationRecountTestOrder)panelSetOrderCollection.GetPanelSetOrder(her2AmplificationRecountTest.PanelSetId);
}
}
public override FinalizeTestResult Finish(AccessionOrder accessionOrder)
{
if (this.m_Score.Contains("2+") == false)
{
HER2AnalysisSummary.HER2AnalysisSummaryTest test = new HER2AnalysisSummary.HER2AnalysisSummaryTest();
if (accessionOrder.PanelSetOrderCollection.Exists(test.PanelSetId, this.m_OrderedOnId, true) == true)
{
this.Distribute = false;
HER2AnalysisSummary.HER2AnalysisSummaryTestOrder testOrder = (HER2AnalysisSummary.HER2AnalysisSummaryTestOrder)accessionOrder.PanelSetOrderCollection.GetPanelSetOrder(test.PanelSetId, this.m_OrderedOnId, true);
testOrder.SetValues(accessionOrder);
}
}
return(base.Finish(accessionOrder));
}
public HER2AmplificationResultGroup2Breast(PanelSetOrderCollection panelSetOrderCollection, HER2AnalysisSummary.HER2AnalysisSummaryTestOrder panelSetOrder) : base(panelSetOrderCollection, panelSetOrder)
{
this.m_InterpretiveComment = "Evidence is limited on the efficacy of human epidermal growth factor 2 (HER2)-targeted therapy in the " +
"small subset of cases with a HER2/chromosome enumeration probe 17 (CEP17) ratio ≥ 2.0 and an average HER2 copy number " +
"of < 4.0 per cell. In the first generation of adjuvant trastuzumab trials, patients in this subgroup who were randomly " +
"assigned to the trastuzumab arm did not seem to derive an improvement in disease-free or overall survival, but there were " +
"too few such cases to draw definitive conclusions. Immunohistochemistry (IHC) expression for HER2 should be used to " +
"complement in situ hybridization (ISH) and define HER2 status. If the IHC result is not 3+ positive, it is recommended " +
"that the specimen be considered HER2 negative because of the low HER2 copy number by ISH and the lack of protein expression.";
}
public HER2AmplificationResultBreast(PanelSetOrderCollection panelSetOrderCollection, HER2AnalysisSummary.HER2AnalysisSummaryTestOrder panelSetOrder) : base(panelSetOrderCollection, panelSetOrder)
{
this.m_ReportReference = "Wolff AC, Hammond MEH, Hicks DG, et al. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in " +
"Breast Cancer. Arch Pathol Lab Med. doi: 10.5858/arpa.2013-0953-SA.";
}
public HER2AmplificationResultGroup4Breast(PanelSetOrderCollection panelSetOrderCollection, HER2AnalysisSummary.HER2AnalysisSummaryTestOrder panelSetOrder) : base(panelSetOrderCollection, panelSetOrder)
{
this.m_InterpretiveComment = "It is uncertain whether patients with an average of ≥ 4.0 and < 6.0 human epidermal growth factor 2 " +
"receptor(HER2) signals per cell and HER2 / chromosome enumeration probe 17(CEP17) ratio of < 2.0 benefit from HER2 - " +
"targeted therapy in the absence of protein overexpression(immunohistochemistry[IHC] 3 +). If the specimen test result is " +
"close to the in situ hybridization (ISH)ratio threshold for positive, there is a higher likelihood that repeat testing will " +
"result in different results by chance alone. Therefore, when IHC results are not 3 + positive, it is recommended that the " +
"sample be considered HER2 negative without additional testing on the same specimen.";
}
public HER2AmplificationResultCollection(PanelSetOrderCollection panelSetOrderCollection, HER2AnalysisSummary.HER2AnalysisSummaryTestOrder panelSetOrder)
{
this.Add(new HER2AmplificationResultGroup2Breast(panelSetOrderCollection, panelSetOrder));
this.Add(new HER2AmplificationResultGroup3Breast(panelSetOrderCollection, panelSetOrder));
this.Add(new HER2AmplificationResultGroup4Breast(panelSetOrderCollection, panelSetOrder));
}
public HER2AmplificationResultGroup3Breast(PanelSetOrderCollection panelSetOrderCollection, HER2AnalysisSummary.HER2AnalysisSummaryTestOrder panelSetOrder) : base(panelSetOrderCollection, panelSetOrder)
{
this.m_InterpretiveComment = "There are insufficient data on the efficacy of human epidermal growth factor receptor 2 (HER2)-targeted " +
"therapy in cases with a HER2 ratio of < 2.0 in the absence of protein overexpression because such patients were not eligible " +
"for the first generation of adjuvant trastuzumab clinical trials. When concurrent immunohistochemistry (IHC) results are " +
"negative (0 or 1+), it is recommended that the specimen be considered HER2 negative.";
}
