Breast cancer diagnostic solutions

Deliver diagnostic confidence

Only from Roche, VENTANA breast cancer diagnostics deliver on three key benefits pathology professionals value: clinical superiority, analytical superiority, and testing efficiency.

> Breast portfolio     > HER2 Dual ISH     > Educational resources     > Publications


 

Featured breast cancer assays

  • FDA cleared antibody
  • Indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.6
  • ER (SP1) is a significant predictor of disease-specific survival.7,8
  • Rapid and consistent results delivered through fully automated platforms and digital pathology solutions
CONFIRM ER (SP1) Rabbit Monoclonal Primary Antibody

  • FDA-approved antibody
  • Higher overall proficiency assessment scores with HER2 (4B5) than with any other clones3
  • Widely adopted and reliable HER2 IHC primary antibody7
  • High concordance with HER2 ISH4,5
PATHWAY HER2 (4B5) Rabbit Monoclonal Primary Antibody

  • Aids in assessing the proliferative activity of normal and neoplastic cells
  • Monoclonal antibody demonstrates increased sensitivity and strong specificity compared with mouse monoclonal antibodies
  • Intense nuclear staining and no adipose (K2) or cell membrane staining can help deliver a confident assessment of tumor aggressiveness.
KI67

  • FDA-approved test
  • Convenient brightfield detection technology to perform a comprehensive analysis of tissue on the slide, and evaluate HER2 gene status with morphological context
  • Identify intratumoral heterogeneity
  • Greatly reduced time to result with full automation1,2
  • Run the test in-house instead of sending it out
INFORM HER2 Dual ISH DNA Probe Cocktail assay

  • FDA cleared antibodies
  • Indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.9
  • Provide significant value as a prognostic factor and response prediction of hormone therapy, even in ER negative patients.10
  • Rapid and consistent results through fully automated platforms and digital pathology solutions
CONFIRM PR (1E2) Rabbit Monoclonal Primary Antibody
Reference List

1. Loftin IR, et al. The new FDA-approved INFORM HER2 Dual ISH assay is concordant to FISH and reproducible in determining HER2 gene status in invasive breast carcinoma. Poster presented at the ASCO Breast Cancer Symposium; 2011; September 8-10: San Francisco, California, USA.
2 Paolini D, Rossoni R, Guardione D, Vrena V. Economical and organizational impact of adopting different in situ hybridization technologies to assess HER2 gene amplification in breast cancer. Poster presented at the 18th Annual European
3. Based on 5 years of data from a leading external quality assessment scheme. Retrieved from http://www.nordiqc.org/epitopes.htm
4. Mayr D, et al. Comprehensive immunohistochemical analysis of Her-2/ neu oncoprotein overexpression in breast cancer: HercepTest™ (Dako) for manual testing and Her-2/neuTest 4B5 (VENTANA) for VENTANA BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Archiv. 2009; 454(3): 241–248.
5. Brügmann A, Lelkaitis G, Nielsen S, et al. Testing HER2 in breast cancer: a comparative study on BRISH, FISH, and IHC. Appl Immunohistochem Mol Morphol. 2011;19(3):203-211.
6. CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: VENTANA Medical Systems, Inc.; 2008.
7. Welsh A, et al. Quantitative Analysis of Estrogen Receptor Expression Shows SP1 Antibody Is More Sensitive Than 1D5. Appl Immunohistochem Mol Morphol. 2013;21(2):139-147
8. Yamamoto-Ibusuki M, Yamamoto Y, Yamamoto S, et al. Comparison of prognostic values between combined immunohistochemical score of estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, Ki-67 and the corresponding gene expression score in breast cancer. Mod Patholo 2013: 26):79–86.
9. 8. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: VENTANA Medical Systems, Inc.; 2008.
10. Liu, S, Cchia SK, Mehl, E, et al. Breast Cancer Res Treat. Progesterone receptor is a significant factor associated with clinical outcomes and effect of adjuvant tamoxifen therapy in breast cancer patients. 2010;119:53-61.

 


Breast cancer publications

Learn what the literature says about Roche breast diagnostic products.

 

Benefits of rabbit monoclonal antibodies compared to mouse antibodies

A comparative study between a novel category of immunoreagents and the corresponding mouse monoclonal antibodies
View on PubMed


 

The reliability of rabbit monoclonal antibodies in the immunohistochemical assessment of estrogen receptors, progesterone receptors, and HER2 in human breast carcinomas
View on PubMed


 

Rabbit monoclonal antibodies show higher sensitivity than mouse monoclonals for estrogen and progesterone receptor evaluation in breast cancer by immuno-histochemistry
View on PubMed


 

Development of new rabbit monoclonal antibody to progesterone receptor (clone SP2): No heat pretreatment but effective for paraffin section immuno-histochemistry
View on PubMed

 

CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody

Quantitative analysis of estrogen receptor expression shows SP1 antibody is
more sensitive than 1D5
View on PubMed


 

Comparison of Anti–Estrogen Receptor Antibodies SP1, 6F11, and 1D5 in Breast Cancer
View on PubMed


 

A systematic comparison of three commercial estrogen receptor assays in a single clinical outcome breast cancer cohort
View on PubMed


 

Hormone receptor expression in invasive breast cancer among Korean women and comparison of 3 antiestrogen receptor antibodies: A multi-institutional retrospective study using
tissue microarrays
View on PubMed


 

Comparison of prognostic values between combined immunohistochemical score of estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, Ki-67 and the corresponding gene expression score in breast cancer
View on PubMed

 

PATHWAY/VENTANA anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest™ (Dako) for manual testing and Her-2/neuTest 4B5 (Ventana) for Ventana BenchMark automatic staining system with correlatt5ion to results of fluorescence in situ hybridization (FISH)
View on PubMed


 

Testing HER2 in breast cancer: a comparative study on BRISH, FISH, and IHC
View on PubMed


 

A new rabbit monoclonal antibody (4B5) for the immunohistochemical (IHC) determination of the HER2 status in breast cancer: Comparison with CB11, fluorescence in situ hybridization (FISH), and interlaboratory reproducibility
View on PubMed


 

Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests
View on PubMed


 

The reliability of rabbit monoclonal antibodies in the immunohistochemical assessment of estrogen receptors, progesterone receptors, and HER2 in human breast carcinomas
View on PubMed

Publications assessing INFORM HER2 Dual ISH DNA Probe Cocktail

Testing HER2 in Breast Cancer-A Comparative Study on BRISH, FISH, and IHC
View on PubMed


 

Dual-color silver-enhanced in situ hybridization for assessing HER2 gene amplification in breast cancer
View on PubMed


 

Comparison of Dual-ISH (DISH) With Fluorescence In Situ Hybridization (FISH) and Correlation With
Immunohistochemical Findings for HER2/Neu Status in Breast Carcinoma
View on PubMed

HER2 Dual ISH

See more of what matters with the INFORM HER2 Dual ISH DNA Probe Cocktail assay

> See for yourself


Breast cancer disease state

 

Breast caner disease stat

15-20% of breast cancer patients overexpress the HER2 protein & are eligible for treatment with highly effective HER2-targeted personalized therapies that improve outcomes.

> Learn more


Real patient stories

Real patient Stories

We’ve told you how we do it. Now we’ll show you why.

> Real patient stories