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Xpert® Breast Cancer STRAT4

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STRAT4 computer generated depiction.

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

The Need

an ill woman listens to a physician
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) Borges PCC, Spencer HB, Barbosa C, Costa V, Furtado A, Leal MC, Lopes C, Ferreira D, Carvalho AL, Dos-Santos-Silva I, Santos LL. XPERT® breast cancer STRAT4 as an alternative method of identifying breast cancer phenotype in Cape Verde (preliminary results). Ecancermedicalscience. 2023 Apr 11;17:1530. doi: 10.3332/ ecancer.2023.1530. PMID: 37138965; PMCID: PMC10151082.

The Solution

a male and a female researchers scanning cepheid test cartridges
Xpert Breast Cancer STRAT4 supports standardized 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
CYFIP1: Cytoplasmic FMR1 interacting protein 1

The Impact

a smiling female doctor attends an elderly woman
  • Fast, clear, and accurate results by STRAT4 can help laboratories in diverse settings address various challenges with IHC/ISH testing to aid in the clinical evaluation of patients. 6
  • May facilitate a cost-efficient, quick, easy, and quality solution in labs facing challenges with IHC.7-9
  • Enables decentralized testing that doesn’t require a PCR laboratory to support breast cancer testing in low- and middle-income countries. 6,7,9
(6) Borges PCC, Spencer HB, Barbosa C, Costa V, Furtado A, Leal MC, Lopes C, Ferreira D, Carvalho AL, Dos-Santos-Silva I, Santos LL. XPERT® breast cancer STRAT4 as an alternative method of identifying breast cancer phenotype in Cape Verde (preliminary results). Ecancermedicalscience. 2023 Apr 11;17:1530. doi: 10.3332/ ecancer.2023.1530. PMID: 37138965; PMCID: PMC10151082.
(7) Marcellin Mugabe, Kenneth E Ho, Deo Ruhangaza, Dan Milner, Belson Rugwizangoga, Victor C Chu, Natalie C Wu, Annaliza Rizo, Jodi M Weidler, Wendy Wong, Michael Bates, Jane E Brock, Use of the Xpert Breast Cancer STRAT4 for Biomarker Evaluation in Tissue Processed in a Developing Country, American Journal of Clinical Pathology, Volume 156, Issue 5, November 2021, Pages 766–776, https://doi.org/10.1093/ajcp/aqab016
(8) El Aje, R, Naya A, Khoaja A, Zaid Y, Oudghiri M, Weidler J, and Karkouri M. A Study Comparing Immunohistochemistry, Fluorescence in situ hybridization, GeneXpert® Breast Cancer STRAT4 Assay for Determining Hormone Receptor, Human Epidermal Growth Factor Receptor 2, Ki67 Status in Invasive Breast Carcinomain Moroccan women. Progress in Microbes and Molecular Biology. 2023; 6, 1; a0000332. doi: 10.36877/pmmb.a0000332.
(9) Erfani P et al. Breast cancer molecular diagnostics in Rwanda: a cost-minimization study of immunohistochemistry versus a novel GeneXpert® mRNA expression assay. Bull World Health Organ 2023;101:10–19 | doi: http://dx.doi.org/10.2471/BLT.22.288800 The Impact The Need The Solution Breast cancer in women is the leading cancer worldwide, with approximately 2.3 million new breast cancer cases every year.

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