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Related Experiment Video

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Pan-cancer multi-omic ERBB2-HER2 characterization using next-generation sequencing and quantitative proteomics.

Allison L Hunt1,2, Jamie Randall3, Jonathan D Ogata2,4

  • 1Women's Health Integrated Research Center, Women's Service Line, Inova Health System, Annandale, VA, USA.

NPJ Precision Oncology
|March 5, 2026
PubMed
Summary

Current diagnostic tests for HER2-targeting therapies are limited. Multi-omic analysis reveals that protein activation, not just gene alterations, is crucial for guiding precision oncology treatment selection.

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Area of Science:

  • Oncology
  • Molecular Biology
  • Genomics

Background:

  • Current FDA-approved molecular testing for HER2 (human epidermal growth factor receptor 2) has limitations in identifying patients who may benefit from HER2-targeting therapies.
  • This is evident in cases where tumors are classified as HER2-negative but still respond to HER2-targeted agents, suggesting a need for improved diagnostic approaches.

Purpose of the Study:

  • To investigate the limitations of current diagnostic methods for HER2-targeting therapies.
  • To characterize ERBB2/HER2 activation at DNA, RNA, protein, and phosphoprotein levels in advanced pan-cancer solid tumors.
  • To assess the concordance between genomic alterations and downstream HER2/EGFR signaling activation.

Main Methods:

  • Integrated multi-omic analysis combining clinical next-generation sequencing (NGS) with CLIA-certified reverse-phase protein array (RPPA) assays.
  • Laser microdissection-enriched tumor samples were used for comprehensive characterization.
  • RPPA was employed for functional pathway activation mapping.

Main Results:

  • Identified patients with ERBB2 genomic/transcriptomic alterations or HER2Total positivity who lacked significant HER2Y1248 activation.
  • Observed significant HER2Y1248 activation, with co-activation of EGFRY1173, in patients without ERBB2 genomic/transcriptomic alterations.
  • Demonstrated weak concordance between ERBB2 genomic/transcriptomic status and downstream HER family signaling activation.

Conclusions:

  • Protein and phosphoprotein analysis is essential for accurately identifying patients who will benefit from HER2- and EGFR-targeted therapies.
  • Current genomic and transcriptomic testing alone is insufficient for guiding treatment selection in precision oncology.
  • Functional proteomic and phosphoproteomic analyses should be integrated into precision oncology pipelines for improved patient stratification.