Immunohistochemical testing of GISTs using CD117 markers: the UK NEQAS ICC & ISH external quality assessment data show significant differences in the performance of methods in regular use - Scorecard - MDSpire

Immunohistochemical testing of GISTs using CD117 markers: the UK NEQAS ICC & ISH external quality assessment data show significant differences in the performance of methods in regular use

  • By

  • Andrew Dodson

  • Suzanne Parry

  • July 17, 2026

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Clinical Scorecard: Evaluation of GIST Immunohistochemistry Using CD117 Markers: Analysis of UK NEQAS ICC & ISH External Quality Assessment Data Reveals Notable Variations in Method Performance

At a Glance

CategoryDetail
ConditionGastrointestinal Stromal Tumour (GIST)
Key MechanismsCD117 (c-KIT) is a tyrosine kinase receptor protein involved in GIST tumorigenesis.
Target PopulationPatients with gastrointestinal stromal tumours (GISTs).
Care SettingClinical laboratories conducting immunohistochemical assessments.

Key Highlights

  • 99.5% of submissions achieved at least acceptable stain quality.
  • Only 0.5% of submissions failed quality assessment.
  • The polyclonal antiserum from Dako Agilent produced the highest quality staining.
  • Clone 9.7 (Roche Diagnostics) produced statistically significantly inferior results.
  • A strong trend for improved quality scores over time was observed.

Guideline-Based Recommendations

Diagnosis

  • CD117 immunohistochemistry is the primary marker for diagnosing GIST.

Management

  • Correct identification of GISTs is crucial for treatment with tyrosine kinase inhibitors.

Monitoring & Follow-up

  • Regular quality assessments of CD117 staining in clinical laboratories are recommended.

Risks

  • Using inferior antibodies like Clone 9.7 may lead to misdiagnosis.

Patient & Prescribing Data

Patients with advanced unresectable or metastatic GIST.

Tyrosine kinase inhibitors such as imatinib and sunitinib are used for treatment.

Clinical Best Practices

  • Use primary antibodies sourced from the same supplier as the automation for optimal staining.
  • Participate in external quality assessment programs for continuous improvement.

Related Resources & Content

Original Source(s)

Immunohistochemical testing of GISTs using CD117 markers: the UK NEQAS ICC & ISH external quality assessment data show significant differences in the performance of methods in regular use

  • by Andrew Dodson, Suzanne Parry

  • July 17, 2026

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