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TEST:
HER2DX

Type:
Laboratory Developed Test
Related tests:
Evidence

News

1m
Implementation of HER2DX Scores into Treatment Decisions in Early-Stage HER2-Positive Breast Cancer. (PubMed, Int J Mol Sci)
The ERBB2 score correlated with HER2 immunohistochemical intensity. In this exploratory real-world cohort, HER2DX provided biologically distinct information beyond traditional immunohistochemistry and was associated with modifications in multidisciplinary treatment decision-making in early-stage HER2-positive breast cancer, warranting prospective validation in larger cohorts.
Observational data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive
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HER2DX
2ms
Assessing biomarkers for patients with breast cancer who are suited for adjuvant therapy. (PubMed, Expert Rev Mol Diagn)
Emerging approaches, including liquid biopsy, AI, and multi-omics integration, offer dynamic insights but require prospective validation. Future progress depends on assay standardization, equitable access, and validation within adaptive clinical trial frameworks, supporting integrated molecular - clinical and AI-enhanced models for personalized therapy.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • mTOR (Mechanistic target of rapamycin kinase)
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HER-2 positive • PIK3CA mutation • HER-2 mutation • PTEN mutation
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HER2DX
4ms
STUDY LINKS REVEAL GENOMICS ASSAYS HER2DX AND DNADX TO RESPONSE TO TRASTUZUMAB DERUXTECAN IN METASTATIC BREAST CANCER (Reveal Genomics Press Release)
"REVEAL GENOMICS...has announced the publication of new research in npj Precision Oncology demonstrating that its HER2DX and DNADX assays are associated with clinical outcomes to trastuzumab deruxtecan (T-DXd) in metastatic breast cancer."
Clinical
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DNADX® • HER2DX
5ms
Quantitative HER2 tissue and plasma profiling predicts the activity of trastuzumab deruxtecan for breast cancer. (PubMed, NPJ Precis Oncol)
Conversely, HER2 immunohistochemical subtypes showed limited predictive value for clinical outcomes. Additionally, elevated TOPO1 expression was associated with worse outcomes with T-DXd in HER2-negative breast cancer, suggesting potential relevance for payload-related markers in predicting T-DXd performance.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 negative • HER-2 expression
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HER2DX
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Enhertu (fam-trastuzumab deruxtecan-nxki)
6ms
HCB-ONC002: HER2DX-guided diagnostic treatment For patients with HER2-positive early-stage breast cancer (2025-521040-37-00)
P2/3, N=224, Recruiting, Fundacio De Recerca Clinic Barcelona-Institut DInvestigacions Biomediques August Pi I Sunyer
New P2/3 trial
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HR negative
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HER2DX
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carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • albumin-bound paclitaxel • cyclophosphamide • epirubicin • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
6ms
Validation of the HER2DX genomic test in first-line advanced HER2-positive breast cancer treated with trastuzumab, pertuzumab, and taxane. (PubMed, NPJ Breast Cancer)
In conclusion, the HER2DX ERBB2 mRNA score provides independent prognostic information in HER2+ advanced breast cancer treated with THP. The HER2DX metastatic prognostic score further improves prognostic accuracy.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
|
HER2DX
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Herceptin (trastuzumab) • Perjeta (pertuzumab)
6ms
Clinical decision impact of HER2DX, an algorithm-powered genomic diagnostic in early-stage HER2-positive breast cancer: results from a prospective real-world study. (PubMed, ESMO Real World Data Digit Oncol)
Physician confidence improved (P < 0.001) and the estimated total cost savings, including direct drug costs, vein access devices, and HER2DX costs, amounted to €98 031. HER2DX impacts clinical management in stage I-III HER2-positive BC by supporting treatment adjustments, enhancing physician confidence, maintaining pCR rates, and reducing health care costs.
Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 expression • EGFR positive
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HER2DX
6ms
Case Report: Personalized management of HER2-positive breast cancer with advanced nodal disease during pregnancy: a clinical case and review. (PubMed, Front Oncol)
The patient subsequently received adjuvant chest wall and nodal region radiotherapy plus trastuzumab-emtansine (T-DM1). This case underscores the value of personalized, multidisciplinary management in PrBC, particularly in patients with high-risk biologic features and advanced nodal disease. Integrating clinical judgment, genomic tools, and adaptive strategies, while accounting for gestational limitations, can optimize oncologic outcomes without compromising fetal safety.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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HER2DX
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Kadcyla (ado-trastuzumab emtansine)
8ms
20th anniversary of adjuvant trastuzumab: reflections on a breakthrough moment. (PubMed, Ann Oncol)
Similarly, while clinical factors and imaging tools may help identify early on patients at higher risk of experiencing TIC, no cardioprotective strategy has yet demonstrated robust and conclusive benefit. Despite the emergence of newer anti-HER2 agents and evolving treatment paradigms, trastuzumab will probably continue to serve as a key therapeutic backbone, especially for patients with lower risk HER2+ eBC.
Review • Journal
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HER-2 overexpression • HER-2 amplification • EGFR positive
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HER2DX
8ms
Associations of the HER2DX Genomic Test with Biological and Pathological Features in HER2-positive Breast Cancer. (PubMed, Clin Cancer Res)
HER2DX reflects key biological and pathological features of HER2+ breast cancer and independently predicts pCR, supporting its utility for individualized treatment decision-making.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 expression
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HER2DX
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Herceptin (trastuzumab)
9ms
HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy. (PubMed, Nat Commun)
HER2DX offers prognostic value and may guide chemotherapy use in older patients with HER2-positive early breast cancer. Clinical Trial Information NCT01104935.
Clinical • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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HER2DX
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Herceptin (trastuzumab)