SARS-CoV-2 Test Development Information

Xpert Breast Cancer STRAT4

Xpert® Breast Cancer STRAT4

Standardized breast cancer ER/PGR/HER2/Ki-67 mRNA biomarker assessment in less than two hours

Ordering Info
  • 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.

    Click here for more information

    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












    ERBB2/HER2 (Xpert vs IHC)




    ERBB2/HER2 (Xpert vs FISH)




    ERBB2/HER2 (Xpert vs. IHC+FISH)








    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.

    • Cepheid - Our Vision for a Better Way
    • Catalog #:

      Xpert® FFPE Lysis Kit
      Number of Tests: 10

    • Catalog #:

      Xpert Breast Cancer STRAT4
      Number of Tests: 10

    • Catalog #:

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

      # For Research Use Only. Not for use in diagnostic procedures.

    • Catalog #:

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

      * CE-IVD. In Vitro Medical Device. Not available in the U.S. Not available in all countries.
      ^ Limited to one per customer.

    • Catalog #:

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

      # For Research Use Only. Not for use in diagnostic procedures.