INFORMATION FOR HEALTHCARE PROFESSIONALS

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THE FIRST GENOMIC TOOL FOR PATIENTS WITH HER2+ BREAST CANCER

A new tool tailored for HER2+ disease
Evaluated in
>2,000 patients
HER2DX® reveals:
• long-term relapse risk
• probability of therapy response
• tumor HER2 expression levels
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

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 >2,000 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

References: 

- 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 risk-score in HER2-positive (HER2+) breast cancer following neoadjuvant and adjuvant anti-HER2-based treatment: an updated survival analysis. Martínez-Sáez O et al. ESMO BC 2023 (data on file).
- 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
.-HER2DX risk-score in early-stage HER2-positive (HER2+) breast cancer: a correlative analysis of 757 patients from the Sweden Cancerome Analysis Network - Breast (SCAN-B) dataset. Pascual T and Villacampa G et al. ESMO BC 2023 (data on file).
-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.
- Independent validation of the HER2DX assay in HER2-positive (HER2+) breast cancer treated with neoadjuvant paclitaxel, trastuzumab and pertuzumab (THP): a correlative analysis from the BiOnHER study. Fullana B et al. ESMO BC 2023 (data on file).
-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. SABCS 2022.
‍- First decision impact study of HER2DX in patients (pts) with HER2-positive (HER2+) early breast cancer. Martínez-Sáez O 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).
- Association of HER2DX with pathological complete response and survival outcomes in HER2-positive breast cancer. Villacampa G. et al. Ann Oncol 2023 Jun 9
- 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).
- 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.
- 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.  
- Validation of a genomic assay in early-stage HER2+ breast cancer treated with trastuzumab and pertuzumab (HP): a correlative analysis from PHERGain phase II trial. Llombart-Cussac A et al. ESMO 2023 (data on file)
‍- Investigating HER2DX genomic assay concordance within HER2-positive breast cancer. Brasó-Marsitany F et al. SABCS 2023 (data on file).

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