CONFIRM Estrogen Receptor (ER) (SP1)
Rabbit Monoclonal Primary Antibody
Breast carcinoma ER positive / Magnification: 40X
Empowering clinical confidence
• Rabbit Monoclonal Primary Antibody
• Pre-diluted, ready-to-use reagent
• Fully automated on Benchmark IHC/ISH
staining platforms
• CE-IVD marked/FDA 510(k) cleared
Accurately identify patients
for hormone receptor targeted therapy
Estrogen receptor (ER) is a powerful predictor of the response to hormone therapy (such as
Tamoxifen) and clinical outcome of breast cancer patients. Run on Ventana BenchMark
IHC/ISH automated slide staining instruments with our advanced detection chemistry,
the CONFIRM ER (SP1) Rabbit Monoclonal Primary Antibody can deliver:
• More precise determination of ER expression status compared to other on-market
clones and assays to ensure eligible patients are identified for hormone therapy1,2,3,10
• Superior sensitivity and specificity in breast carcinoma samples compared to
mouse monoclonal antibodies4,10
• Faster, more accurate results with complete automation and ready-to-use reagents5
CONFIRM ER (SP1) is shown to have a high concordance with the ER (6F11) antibody
(96% concordance) but demonstrates a superior signal-to-noise ratio. This is particularly
important in low-expressing ER+ cases. Difficulties with the interpretation of clone
6F11 staining patterns due to weak granular/punctate nuclear staining can lead to falsepositive results.1, 6
HER-2/neu
(4B5)
HER-2
Dual ISH
PR
(1E2)
ER
(SP1)
Ki-67
(30-9)
CONFIRM ER (SP1) is part of the Ventana Breast
Cancer Diagnostics solution.
References
1. Tubbs R, et al. Clinical utility of the CONFIRM
anti-Estrogen Receptor (SP1) Rabbit Monoclonal
Antibody. White Paper. Ventana Medical Systems,
Inc. Tucson, Arizona. May 2012.
2. Cheang M, et al. Immunohistochemical Detection
Using the New Rabbit Monoclonal Antibody SP1 of
Estrogen Receptor in Breast Cancer Is Superior
to Mouse Monoclonal Antibody 1D5 in Predicting
Survival. JCO. 2006; 24(36): 5637-5644.
3. Welsh A, et al. Quantitative Analysis of Estrogen
Receptor Expression Shows SP1 Antibody Is More
Sensitive Than 1D5. Appl Immunohistochem Mol
Morphol. 2012. [Published online ahead of print July
19 2012]. DOI: 10.1097/PAI.0b013e31825d73b2.
4. Rossi S, et al. Rabbit monoclonal antibodies: a
comparative study between a novel category of
immunoreagents and the corresponding mouse
monoclonal antibodies. Am J Clin Pathol. 2005;
124(2): 295-302.
5. Assessment Run B13 2012. Estrogen receptor (ER).
NordiQC. http://www.nordiqc.org/Run-35-B13-H1/
Assessment/assessment-B13-ER.htm. Updated 10
JUL 2012. Accessed 28 AUG 2012.
6. Rakha E, et al. Low–Estrogen Receptor–Positive
Breast Cancer: The Impact of Tissue Sampling,
Choice of Antibody, and Molecular Subtyping. JCO.
2012; 30(23): 2929-2930.
7. BenchMark XT IHC/ISH Automated Slide
Preparation Systems [Operator’s Manual]. Tucson,
AZ: Ventana Medical Systems, Inc.; 2010.
8. BenchMark ULTRA IHC/ISH Automated Slide
Preparation Systems [Operator’s Manual]. Tucson,
AZ: Ventana Medical Systems, Inc.; 2011.
9. CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit
Monoclonal Primary Antibody [package insert].
Tucson, AZ: Ventana MedicalSystems, Inc.; 2013.
10.Bae et al. 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. Am J Surg Pathol. 2012;
36(12):1817–1825.
CONFIRM ER (SP1) delivers on three key benefits
that are valued by pathology professionals:
Clinical superiority
SP1 more accurately identifies breast cancer patients for hormone therapy:
• Cheang et al. conclude 1D5 failed to identify 6% of ER-positive patients compared to
SP1, and that SP1 is 8% more sensitive, demonstrating that “SP1 represents an improved
standard for ER immunohistochemistry assessment in breast cancer.” 2
• Welsh et al. conclude that “SP1 is more sensitive than 1D5, and displays a stronger
signal-to-background ratio. This would suggest that, in addition to its benefits for cost
efficiency, the use of SP1 in a clinical setting may help reduce the false-negative rate.”3
• Bae et al. demonstrate that ER(SP1) was more sensitive in identifying ER expression
in tumours than the mouse monoclonal clones 1D5 and 6F11 as supported by positive
correlation to overall survival.10
Analytical superiority
Specific and sensitive pre-diluted rabbit monoclonal antibodies help you diagnose
precisely and confidently:
• Ready-to-use reagents, like CONFIRM ER (SP1), consistently demonstrate superior
performance when compared to concentrated antibodies that are used in in-house
validated assays.5
• Rossi et al. conclude through a comparison of RbMAbs against the corresponding
MMAbs that RbMAbs clearly demonstrated a significant increase in terms of sensitivity4
• CONFIRM ER (SP1) is shown to have a high concordance with the ER (6F11) antibody
(96% concordance) but demonstrates a superior signal-to-noise ratio.1 This is
particularly important in low-expressing ER+ cases. Difficulties with the interpretation
of 6F11 staining patterns due to weak granular/punctate nuclear staining may lead to
false-positive results. 6
Testing efficiency
Rapid and consistent results delivered through fully automated platforms, ready to use
reagents and digital pathology:
• Protocols on BenchMark IHC/ISH staining platforms show time to result of ~ 3.5 hrs 7, 8
• Product development verification and validation studies show reproducibility for
inter and intra-platform, lab and reader 9
• Maximise workflow efficiency with digital pathology
CONFIRM ER (SP1) Ordering information
Product name
Catalogue number
Order number
Quantity
CONFIRM anti-Estrogen Receptor (ER)
(SP1) Rabbit Monoclonal Primary Antibody
790-4324
05278406001
50 tests
CONFIRM anti-Estrogen Receptor (ER)
(SP1) Rabbit Monoclonal Primary Antibody
790-4325
05278414001
250 tests
Roche Diagnostics (Schweiz) AG
Industriestrasse 7
CH-6343 Rotkreuz
Switzerland
Tel: +41 (0)41 799 61 00
Fax: +41 (0)41 799 65 45
www.roche.com
www.ventana.com
© 2013 Ventana Medical Systems, Inc.
VENTANA, the VENTANA logo,
BENCHMARK and CONFIRM are
trademarks of Roche. All other trademarks
are the property of their respective owners.
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06509428001
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Empowering | Clinical Confidence