Whitepaper
12m Read
June 16, 2025
COMMUNITY AND GLOBAL HEALTH
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The Need
Breast cancer biomarker ER/PGR/HER2/Ki-67 results need to be dependable and objective
- Clinicians need more reliable ER/PGR/HER2/Ki-67 assessment in FFPE tumor tissues.
- 5% of HER2 IHC results are equivocal based upon guide line recommended classifications.1
- Resolving HER2 IHC2+ equivocal results with FISH is challenging.1-4
- Technical and observer variability can lead to approximately 20% inaccurate ER and PGR results.5
- Ki-67 IHC scores deviate due to a lack of standardization.6
(1)Wolff AC et al. Recommendations for Human Epidermal Growth Factor Receptor
(2)Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013.
(3)Starczynski J et al. HER2 Gene Amplification in Breast Cancer. A Rogues' Gallery of Challenging Diagnostic Cases: UKNEQAS Interpretation Guidelines and Research Recommendations. AM J Clin Pathol. 2012 Apr;137(4):595-605.
(4)Rakha A et al. Updated UK Recommendations for HER2 assessment in breast cancer. Clin Pathol. 2015 Feb;68(2):93-99.
(5)Hammond MEH et al. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer. J Clin Onc. 2010 Feb 23; 28(16): 2784-2795.
(6)Polley MYC et a.l An International Ki67 Reproducibility Study. J Natl Cancer Ins. 2013 Dec 18;105(24):1897-906.
(2)Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013.
(3)Starczynski J et al. HER2 Gene Amplification in Breast Cancer. A Rogues' Gallery of Challenging Diagnostic Cases: UKNEQAS Interpretation Guidelines and Research Recommendations. AM J Clin Pathol. 2012 Apr;137(4):595-605.
(4)Rakha A et al. Updated UK Recommendations for HER2 assessment in breast cancer. Clin Pathol. 2015 Feb;68(2):93-99.
(5)Hammond MEH et al. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer. J Clin Onc. 2010 Feb 23; 28(16): 2784-2795.
(6)Polley MYC et a.l An International Ki67 Reproducibility Study. J Natl Cancer Ins. 2013 Dec 18;105(24):1897-906.
The Solution
Xpert® Breast Cancer STRAT4 paves the way for a standardized, precise and reliable ER/PGR/HER2/Ki-67 mRNA assessment in less than 2 hours
- Xpert Breast Cancer STRAT4 delivers semi-quantitative determination of ER/PGR/HER2/Ki-67 mRNA levels in FFPE invasive breast cancer sections
- CYFIP1* reference gene is used for sample normalization
- Three controls included in each test
- Software report allows for objective and easy result interpretation
- External FFPE controls# available for identifying errors, shifts, trends and operator variabilities
CYFIP1: Cytoplasmic FMR1 interacting protein 1
# For Research Use Only. Not for use in diagnostic procedure. Not reviewed by any regulatory body.
# For Research Use Only. Not for use in diagnostic procedure. Not reviewed by any regulatory body.
The Impact
Xpert Breast Cancer STRAT4 standardizes reproducible ER/PGR/HER2/Ki-67 assessment
Xpert Breast Cancer STRAT4 results are highly concordant with ER/PGR/Ki-67 IHC and IHC/FISH (HER2)7Xpert Breast Cancer STRAT4 vs. IHC biomarker assessment PPA NPA OPAESR1/ER 97.2% 95.0% 97.5%PR/PGR 89% 92.9% 89.8%ERBB2/HER2 (Xpert vs IHC) 100% 92.4% 93.3%ERBB2/HER2 (Xpert vs FISH) 100% 92.0% 93.3%ERBB2/HER2 (Xpert vs. IHC+FISH) 100% 91.2% 92.4%MKi-67/Ki-67 88.7% 100% 90.5%Positivity detection cut-offs of Xpert Breast Cancer STRAT4 for ER/PGR/HER2 correlate with those in ASCO-CAP, St. Gallen Consensus and ESMO Guidelines.1,5,8,9
- Clear and accurate results empower oncologists.
- Enables flexibility, simplicity and random access for a streamlined workflow 24/7.
- Easy and fast test implementation.
- Internal controls meet quality management requirements.
- Robust test and workflow that doesn't require a PCR laboratory.
Xpert Breast Cancer STRAT4 results are highly concordant with ER/PGR/Ki-67 IHC and IHC/FISH (HER2)7Xpert Breast Cancer STRAT4 vs. IHC biomarker assessment PPA NPA OPAESR1/ER 97.2% 95.0% 97.5%PR/PGR 89% 92.9% 89.8%ERBB2/HER2 (Xpert vs IHC) 100% 92.4% 93.3%ERBB2/HER2 (Xpert vs FISH) 100% 92.0% 93.3%ERBB2/HER2 (Xpert vs. IHC+FISH) 100% 91.2% 92.4%MKi-67/Ki-67 88.7% 100% 90.5%Positivity detection cut-offs of Xpert Breast Cancer STRAT4 for ER/PGR/HER2 correlate with those in ASCO-CAP, St. Gallen Consensus and ESMO Guidelines.1,5,8,9
(7)Xpert® Breast Cancer STRAT4 Package Insert. Sunnyvale. USA. 2017
(8)Gnant M et al. St. Gallen/Vienna 2015: A Brief Summary of the Consensus Discussion. Breast Care. 2015 Apr;10(2):124-130.
(9)Senkus et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v8-30.# For Research Use Only. Not for use in diagnostic procedures.* CE-IVD. In Vitro Medical Device. Not available in the U.S. Not available in all countries.^ Limited to one per customer.
(8)Gnant M et al. St. Gallen/Vienna 2015: A Brief Summary of the Consensus Discussion. Breast Care. 2015 Apr;10(2):124-130.
(9)Senkus et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v8-30.# For Research Use Only. Not for use in diagnostic procedures.* CE-IVD. In Vitro Medical Device. Not available in the U.S. Not available in all countries.^ Limited to one per customer.
Insights
Article
40m Read
May 21, 2025
COMMUNITY AND GLOBAL HEALTH