Sensitive and quantitative monitoring of BCR-ABL mRNA in patients with chronic myelogenous leukemia (CML)
Used in conjunction with GeneXpert® technology, Xpert Breast Cancer STRAT4 simplifies breast cancer biomarker assessment through semi-automated sample preparation, automated RNA isolation, reverse transcription, amplification by real-time PCR and detection. The entire process happens within a patented cartridge-based system.
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.
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.
Xpert Breast Cancer STRAT4 standardizes reproducible ER/PGR/HER2/Ki-67 assessment
- 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)7
|Xpert Breast Cancer STRAT4 vs. IHC biomarker assessment||PPA||NPA||OPA|
|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%|
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.
Xpert® Breast Cancer STRAT4
Number of Tests: 10Catalog #: GXBSTRAT4-CE-10
FFPE Lysis Kit Number of Tests: 10Catalog #: GXFFPE-LYSIS-CE-10
Xpert Breast Cancer STRAT4 StartPAK∧ containing Xpert FFPE Lysis Kit and Xpert Breast Cancer STRAT4 Number of Tests: 20Catalog #: GXBCSTRAT4-SPAK1*
Xpert Breast Cancer STRAT4 FFPE Controls# Number of Tests: 1 set for 3 testsCatalog #: BCSTRAT4-BU1
Xpert Breast Cancer STRAT4 FFPE Controls# Number of Tests: 5 sets for 15 testsCatalog #: BCSTRAT4-BU2
# 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.