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Test Information
Home / Tests / Oncology/Genetics / Xpert Breast Cancer STRAT4

Xpert® Breast Cancer STRAT4

Standardized breast cancer ESR1/PGR/ERBB2/MKi67 mRNA biomarker assessment in less than two hours

Xpert<sup>®</sup> Breast Cancer STRAT4

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.

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.

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.

The Impact

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
ESR1/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.

Ordering Info

Xpert® Breast Cancer STRAT4

Number of Tests: 10

Catalog #: GXBCSTRAT4-CE-10

Xpert® Breast Cancer STRAT4

FFPE Lysis Kit Number of Tests: 10

Catalog #: GXFFPE-LYSIS-CE-10

Xpert® Breast Cancer STRAT4

Xpert Breast Cancer STRAT4 StartPAK containing  Xpert FFPE Lysis Kit and Xpert Breast Cancer STRAT4 Number of Tests: 20

Catalog #: GXBCSTRAT4-SPAK1*

Xpert® Breast Cancer STRAT4

Xpert Breast Cancer STRAT4 FFPE Controls# Number of Tests: 1 set for 3 tests

Catalog #: BCSTRAT4-BU1

Xpert® Breast Cancer STRAT4

Xpert Breast Cancer STRAT4 FFPE Controls# Number of Tests: 5 sets for 15 tests

Catalog #: 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.

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