INFORMATION FOR HEALTHCARE PROFESSIONALS

HER2DX logo

THE FIRST GENOMIC TOOL FOR PATIENTS WITH HER2+ BREAST CANCER

A new tool tailored for HER2+ disease
Evaluated in
>5,000 patients
HER2DX® reveals:
• long-term relapse risk
• probability of therapy response
• tumor HER2 expression levels
Information about HER2DX clinical validation
Image of 1 out of 5 women

1 in 5 women

with breast cancer has
HER2+ disease

World icon

> 450,000

cases diagnosed
every year worldwide

Clock image 2 minutes

Every 2 minutes

a woman is diagnosed with HER2+ breast cancer

Human Epidermal Growth Factor
Receptor-2 Positive is

one of the most
aggressive types
of breast cancer

HER2+ breast cancer is a

clinical unmet need

To date, there are no tools to predict
the beneficial effect of targeted therapy
and the risk of recurrence

A sophisticated tool
for an accurate diagnosis

HER2DX® is the first
genomic tool for patients
with early-stage HER2+
breast cancer

HER2DX® measures the expression of 27 genes
from Formalin-Fixed, Paraffin-Embedded (FFPE) breast cancer tissues.
Specifically, HER2DX® evaluates the following biological processes:

HER2DX packaging

Immune
infiltration

Luminal
differentiation

Tumor cell
proliferation

HER2
amplicon
expression

The biological information from these 4 gene signatures is combined
with clinical data such as tumor stage and nodal stage.

Luminal icon
Immune
Proliferation of tumor icon
HER2
Tumor stage icon
Luminal
HER2 image
Proliferation
Immune cell icon
Tumor stage
Nodal stage icon
Nodal stage
A line that appoints at HER2DX
HER2DX

New

REPORT

Image of the four pages of the HER2DX report
HER2DX score bar
Icon of time meaning the most recent

Updated version with the most recent studies conducted on HER2DX®.

Icon of bars meaning more visual results

More visual results, the scores are shown in representation with their scale.

Icon of guide meaning extensive description

Extensive description and guidance for reading the results, their clinical significance and supporting data.

Graphic bars meaning interpretation of results

Extensive explanation
of the scores for a better interpretation of the results.

DOWNLOAD A SAMPLE REPORT
Summary Safety and Performance
Instructions For Use

HER2DX® included in the Spanish Society of Medical Oncologists (SEOM) guidelines.

Screenshot of the SEOM guidelines article
"In HER2-positive disease, the HER2DX 27-gene test has recently emerged as a useful clinical tool [22-25]. The HER2DX test provides two independent scores indicating prognosis when treated with -based CT (HER2DXrisk-score),and the probability of achieving a pathological complete response following trastuzumab based therapy(HER2DX pCR-score). Thus, HER2DX can help to identify suitable candidates for escalation and deescalation treatment strategies in some clinical situations, even when this tool needs additional validation (II, B)."
Based on a systematic review of relevant studies and on the consensus of experts from GEICAM, SOLTI, and SEOM.
•Ayala de la Peña,F., Antolín Novoa,S., Gavilá Gregori,J. et al. SEOM-GEICAM-SOLTI  clinicalguidelinesforearly-stagebreastcancer(2022).ClinTranslOncol(2023).  https://doi.org/10.1007/s12094-023-03215-4
•Prat A,Guarneri V, Pascual T, Brasó-Maristany F, Sanfeliu E, Paré L. Development and validation of the new HER2DX assay for predicting pathological response and survival outcome in early-stage HER2-positive breast cancer. Lancet Oncol.2022;25:1–5.  https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(21)00595-8/  fulltext
•Tolaney SM, Tarantino P,GrahamN,TayobN,ParèL,VillacampaGetal.Adjuvant  paclitaxelandtrastuzumabfornode-negative,HER2-positivebreastcancer:final  10-yearanalysisoftheopen-label,single-arm,phase2APTtrial.LancetOncol.  2023;24(3):273–85.~[https://doi.org/10.1016/S1470-2045(23)00051-7](https://doi.  org/10.1016/S1470-2045(23)00051-7)•Bueno-MuiñoC,EchavarríaI,López-TarruellaS,Roche-MolinaM,DelMonte-Millán  M,MassarrahTetal.AssessmentofagenomicassayinpatientswithERBB2 -  positivebreastcancerfollowingneoadjuvanttrastuzumab-basedchemotherapy  withorwithoutPertuzumab.JAMAOncol.2023;27:e230187.[https://doi.org/10.1001/  jamaoncol.2023.0187]•WaksAG,OgayoER,ParéL,Marín-AguileraM,Brasó-MaristanyF,GalvánPetal.  AssessmentoftheHER2DXAssayinPatientsWithERBB2 -PositiveBreastCancer  TreatedWithNeoadjuvantPaclitaxel,Trastuzumab,andPertuzumab.JAMA  Oncol.2023;27:e230181.[https://doi.org/10.1001/jamaoncol.2023.0181](https://doi.  org/10.1001/jamaoncol.2023.0181).•VillacampaG,TungNM,PernasS,ParéL,Bueno-MuiñoC,etal.AssociationofHER2DX  withpathologicalcompleteresponseandsurvivaloutcomesinHER2-positivebreast  cancer.~https://www.annalsofoncology.org/article/S0923-7534(23)00721-4/fulltext

HER2DX® has been validated in >5,000 patients

0

Risk
Score

0

pCR Likelihood
Score

0

ERBB2
Score

Risk Score
n=1,341

pCR Likelihood
Score
n=548

ERBB2 Score
n=353

Articles:



‍

- A multivariable prognostic score to guide systemic therapy in early-stage HER2-positive breast cancer:a retrospective study with an external evaluation. Prat A, et al. Lancet Oncol. 2020 Nov;21(11):1455-1464.
‍- Development and validation of the new HER2DX assay for predicting pathological response and survival outcome in early-stage HER2-positive breast cancer. Prat A et al. EBioMedicine. 2022 Jan 3;75:103801.
- HER2DX genomic test in HER2-positive/hormone receptor-positive breast cancer treated with neoadjuvant trastuzumab and pertuzumab: A correlative analysis from the PerELISA trial. Guarneri V, et al. EBioMedicine 2022 Nov;85:104320.
- Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. Tolaney SM. et al. Lancet Oncol 2023 Feb;24(3):273-285.
-Assessment of the HER2DX Assay in Patients With ERBB2-Positive Breast Cancer Treated With Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab. Waks AG, et al. JAMA Oncol. 2023 Apr 27.
-Assessment of a Genomic Assay in Patients With ERBB2-Positive Breast Cancer Following Neoadjuvant Trastuzumab-Based Chemotherapy With or Without Pertuzumab. Bueno-Muiño C, et al. JAMA Oncol. 2023 Apr 27.
- Association of HER2DX with pathological complete response and survival outcomes in HER2-positive breast cancer. Villacampa G. et al. Ann Oncol 2023 Jun 9
- Patritumab deruxtecan in HER2-negative breast cancer: part B results of the window-of-opportunity SOLTI-1805 TOT-HER3 trial and biological determinants of early response. Brasó-Maristany F et al. Nat Commun 2024
-HER2DX Genomic Assay in HER2-positive Early Breast Cancer Treated with Trastuzumab and Pertuzumab: A Correlative Analysis from PHERGain Phase II Trial. Llombart-Cussac A et al Clin Can Res 2024.
- Prognostic value of HER2DX in early-stage HER2-positive breast cancer: a comprehensive analysis of 757 patients in the Sweden Cancerome Analysis Network - Breast Dataset (SCAN-B). ESMO Open. 2024 Mar; 9(3): 102388.
‍- Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer. Marín-Aguilera M et al. ESMO Open . 2024 Mar 6;9(3):102903.
‍-Management of early-stage HER2-positive breast cancer andattitudes towards HER2DX test in Spain: insights from a nationwide survey.Martínez-Sáez O et al. Clin Transl Oncol. 2024.
-Adjuvant Trastuzumab Emtansine Versus Paclitaxel plus Trastuzumab for Stage I HER2+ Breast Cancer: 5-year results and correlative analyses from ATEMPT (TBCRC033). Tarantino P, et al. JCO 2024.
‍- HER2DX genomic test in early-stage HER2-positive breast cancer. Tolaney S et al. ESMO Open 2024.
- HER2DX in HER2-positive inflammatory breast cancer: correlative insights and comparative analysis with noninflammatory breast cancers. Lynce F et al ESMO Open 2025
- Clinical Decision Impact of HER2DX, an Algorithm-Powered Genomic Diagnostic, in Early-Stage HER2-Positive Breast Cancer: Results from a Prospective Real-World Study. Martínez-Sáez O et al. ESMO Real World Data and Digital Oncology 2025
- HER2DX and survival outcomes in early-stage HER2-positive breast cancer: an individual patient-level meta-analysis of 2,518 patients from eleven studies. Villacampa G et al. Lancet Oncol 2025
‍- Associations of the HER2DX Genomic Test with Biological and Pathological Features in HER2-positive Breast Cancer. Sanfeliu et al. ClinCancer Res. 2025 Dec 1
‍- HER2DX ERBB2 score in advanced HER2-positive gastric cancer treated with trastuzumab and chemotherapy. Pesántez D et al. ESMO Open2025.
- HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy. Nozawa K et al. Nature Communications, 2025.
- HER2DX ERBB2 mRNA score in first-lineadvanced HER2-positive breast cancer treated with chemotherapy, trastuzumab,and pertuzumab. Sánchez-Bayona R et al. NPJ Breast Cancer 2025.

Abstracts (data on file): 

- Research-based HER2DX in patients with early-stage HER2-positive (HER2+) breast cancer treated in theN9831 phase III clinical trial. Brasó-Maristany F et al. ESMO BC 2022
- Assessing the Effect of Single Dose Trastuzumab and Pertuzumab (HP) on Biological Changes and Pathological Complete Response (pCR) in ERBB2+ Breast Cancer: Results from the neoadjuvant BiOnHER study. Gómez-Serra N et al. ESMO 2023.
 - Independent validation of HER2DX ERBB2 mRNA score to predict HER2-positive (HER2+), HER2-low and HER2-0 status in breast cancer. Sanfeliu E et al. ESMO BC 2023 (data on file).
‍- Combined analysis of the HER2DX genomic tool in adjuvant APT and ATEMPT trials. Tarantino P et al. ESMO BC 2023 (data on file).
‍- Prospective Validation of HER2DX in Early HER2+ Breast Cancer: Operational Feasibility of Centralized Genomic Screening in the DEFINITIVE Trial. Real-Time Insights from the First 80 Screened Patients.González-Rodríguez M et al. SABCS 2025
.-Development of the HER2DX Predictor of Brain Metastasis in Advanced HER2-Positive Breast Cancer Treated with First-Line THP.Sánchez-Bayona R et al. SABCS 2025.
‍- Central Reassessment of HER2 Status in HER2-PositiveTumors Identified as ERBB2-Low by the HER2DX Genomic Test.Martínez-Sáez O et al. ESMO Breast 2025.
‍- HER2DX genomic test in HER2-positive breast cancertreated with 15 weeks ofneoadjuvant paclitaxel, trastuzumab, and pertuzumab (THP):Final analysis from theBiOnHER clinical trial. Fullana-Grimalt B et al. ASCO2025
‍- Predicting pathologic complete response (pCR) fromclinicopathologic variables and HER2DX genomic test in stage II/III HER2+breast cancer treated with taxane,trastuzumab, and pertuzumab (THP): Secondaryresults from the EA1181/CompassHER2 pCR trial. Tung N.M et al. ASCO 2025. 

Guidelines:
‍

- SEOM‑GEICAM‑SOLTI clinical guidelines for early‑stage breast cancer (2022). Ayala de la Peña et al. ClinTransl Oncol. 2023
‍- SEOM-GEICAM-SOLTI clinical guidelines in advanced breastcancer (UPDATE 2025)
‍- AGO 2025: Prognostic and Predictive Factors. AGO Breast Committee 2025
- Understanding breast cancer complexity to improve patientoutcomes: The St Gallen International Consensus Conference for the PrimaryTherapy of Individuals with Early Breast Cancer 2023. Gallen ConsensusConference. Curigliano G et al. Annals of Oncology 2023

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REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS S.L.

The HER2DX® test in the United States is performed in a CLIA-certified (CLIA#: 34D2302687), CAP-accredited (CAP#: 9841153) clinical laboratory.  
In Europe, the HER2DX® test is currently undergoing CE marking and is provided in collaboration with Hospital Clinical of Barcelona under the exemption set forth in Article 5(5) of Regulation (EU) 2017/746 (IVDR).