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Breast cancer IHC/ISH portfolio

Six stained slides of the Roche Diagnostics breast cancer IHC/ISH assay portfolio offering.

Breast Cancer is personal and we believe that diagnostics should be too

Since 1991, Roche Tissue has battled cancer with innovation

Breast cancer claims more than 600,000 lives worldwide each year.  Every breast tissue sample you receive represents someone’s life – their questions, hopes and aspirations are in your hands. We are inspired by the work you do for patients every day.  Roche remains committed to contributing to better improved outcomes in breast cancer by bringing you the most comprehensive panel of advanced diagnostic tools that have the potential to profoundly change lives.

Clinical Utility

  • Roche breast cancer portfolio solution provides you with all of the diagnostic assays and FDA Approved companion diagnostic bio-markers clinicians and patients need in the shortest possible time.  

Superior Specificity and Sensitivity

  • Specific and sensitive rabbit monoclonal antibodies, best-in-class probes and powerful detection systems help you diagnose precisely and confidently.

Testing Efficiency

  • Our comprehensive breast cancer portfolio delivers fully automated assays on market leading platforms, with digital pathology and workflow solutions that reduce labor costs, free resources and reduce time to results.

 

Reimagining HER2 Testing – Our mission compels us to make even our best tools better

PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Antibody
Expanding access to targeted therapy for breast cancer patients 
  • The new HER2-low indication uses the proven technology of the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody
  • The FDA approved HER2-low indication uses a lower scoring cut-off, allowing patient stratification within a new subtype of breast cancer that has some HER2 proteins on the cell surface, but not enough to be classified as HER2-positive.11
  • Indicated as an aid in the assessment of patients with HER2-low status for whom ENHERTU® is being considered as a treatment option
Learn more
PATHWAY antiHER2/neu (4B5) Rabbit Monoclonal Primary Antibody Identifying HER2-low expression
The PATHWAY HER2 (4B5) Primary Antibody empowers you to: 
  • Achieve consistently high proficiency assessment scores with HER2 (4B5) antibody, compared to other clones3
  • Employ the most widely adopted and reliable HER2-IHC primary antibody3
  • Demonstrate high concordance with HER2 FISH4,5
Learn more
PATHWAY HER2 (4B5) Primary Antibody stain on slide with QR code for tracking and collaboration.
VENTANA HER2 Dual ISH DNA Probe Cocktail Assay

Our reinvented VENTANA HER2 Dual ISH DNA Probe Cocktail builds upon the elements that made the original INFORM product successful. 

  • An FDA approved and fully automated brightfield solution, allows for comprehensive analysis and evaluation of HER2 gne status within morphologic context with archivable results
  • New detection chemistry with improved anti-hapten technology results in unparalleled signal without increased background1
  • Improved performance in turn-around time and first pass rates2
Learn more
VENTANA HER2 Dual ISH DNA Probe Cocktail Assay slide with QR code for tracking and collaboration.

Featured Assays - Confidently navigate the complexities of breast cancer

CONFIRM ER (SP1) Rabbit Monoclonal Primary Antibody stain
CONFIRM ER (SP1) Rabbit Monoclonal Primary Antibody

CONFIRM ER (SP1) is an 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 PR (1E2) Rabbit Monoclonal Primary Antibody stain
CONFIRM PR (1E2) Rabbit Monoclonal Primary Antibody

CONFIRM PR (1E2) is an FDA cleared antibody indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.9

  • Provides 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 anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody stain
CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody
  • Aids in assessing the proliferative activity of normal and neoplastic cells
  • Rabbit 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
VENTANA anti-E-cadherin (36) Mouse Monoclonal Primary Antibody stain
VENTANA anti-E-cadherin (36)  Mouse Monoclonal Primary Antibody

VENTANA E-cadherin (36) antibody is directed against the cytoplasmic domain of the human transmembrane protein E-cadherin expressed as a part of the cell-cell adhesion complex in epithelial tissues.²³ Reduction or loss of expression is associated with invasive carcinoma and possibly metastasis in a variety of carcinomas. This antibody may be used to aid in the differentiation of in situ and/or invasive lobular carcinoma from in situ and/or invasive ductal carcinoma of the breast.

Mammaglobin (31A5) Rabbit Monoclonal Antibody
Mammaglobin (31A5) Rabbit Monoclonal Antibody

Use of this antibody is indicated as an aid in the identification of metastatic breast carcinomas within the context of an antibody panel, clinical history and a qualified pathologist.25 When combined with other breast-restricted  markers such as GCDFP-15, an overall sensitivity for breast carcinoma of 84% has been achieved.25

World-class antibodies to stratify breast cancer

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World-class antibodies to stratify breast cancer

Product name Catalog number Ordering code Quantity
CA-125 (OC125) Mouse Monoclonal Antibody 760-2610 05267269001 50 tests
Calponin-1 (EP798Y) Rabbit Monoclonal Antibody 760-4376 05435684001 50 tests
E-cadherin (36) Mouse Monoclonal Primary Antibody, VENTANA 790-4497 05905290001 50 tests
E-cadherin (EP700Y) Antibody 760-4440 05973872001 50 tests
Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, CONFIRM 760-4324 05278406001 50 tests
Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, CONFIRM 790-4325 05278414001 250 tests
FOXA1(2F83) Mouse Monoclonal Primary Antibody 760-4937 07292848001 50 tests
GATA3 (L50-823) Mouse Monoclonal Primary Antibody 760-4897 07107749001 50 tests
GCDFP-15 (EP1582Y) Rabbit Monoclonal Antibody 760-4386 05463530001 50 tests
GLIAL Fibrillary Acidic Protein (EP672Y) Rabbit Monoclonal Antibody 760-4345 05269784001 50 tests
Growth Hormone (polyclonal) 760-2804 05268257001 50 tests
Human Placental Lactogen (hPL) (polyclonal) 760-4443 05973830001 50 tests
HER2 Dual ISH DNA Probe Cocktail, VENTANA 760-6072 08314365001 30 tests
HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody, PATHWAY 790-2991 05278368001 50 tests
Ki-67 (30-9) Rabbit Monoclonal Primary Antibody, CONFIRM 790-4286 05278384001 50 tests
Mammaglobin (31A5) Rabbit Monoclonal Antibody 760-4263 05269253001 50 tests
P53 (BP53-11) Primary Antibody 760-2542 05267102001 50 tests
P53 (DO-7) Primary Antibody, CONFIRM 800-2912 05278775001 50 tests
P57 (Kp10) Mouse Monoclonal Primary Antibody 760-4617 06523897001 50 tests
p63 (4A4) Mouse Monoclonal Primary Antibody, VENTANA 790-4509 05867061001 50 tests
P120 CATENIN (98) Mouse Monoclonal Primary Antibody, VENTANA 790-4517 05867088001 50 tests
PAX8 (MRQ-50) Mouse Monoclonal Primary Antibody 741-4860 08008540001 50 tests
PLAP (NB10) 760-2664 05267757001 50 tests
Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody 790-2223 05277990001 50 tests
Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody 790-4296 05278392001 250 tests
PTEN (SP218) Rabbit Monoclonal Primary Antibody 790-5097 07970200001 50 tests
Topoisomerase IIα (JS5B4) Rabbit Monoclonal Primary Antibody 790-4371 0547933900 50 tests  

Related information

References
  1. Ventana Product Document Library. Interpretation Guide for VENTANA HER2 Dual ISH DNA Probe Cocktail assay; staining for breast carcinoma.
  2. Ventana Product Document Library. Package Insert, VENTANA HER2 Dual ISH DNA Probe Cocktail
  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.
  11. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-her2-low-breast-cancer : Accessed October 2, 2022.

 

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