Logotipo de Cepheid
Solicitar información
Ubicación/Idioma

{{headingText}}

{{paragraphText}}

{{continueBtnLabel}}

{{initials}}
Main Menu
Ubicación/Idioma

{{headingText}}

{{paragraphText}}

{{continueBtnLabel}}

Solicitar información
Solicitar información

Xpert® Breast Cancer STRAT4

Order Now
STRAT4 computer generated depiction.

Valoración estandarizada de los biomarcadores de ARNm ESR1, PGR, ERBB2 y MKi67 para cáncer de mama en menos de dos horas

La necesidad

an ill woman listens to a physician
Los resultados de los biomarcadores ER/PGR/HER2/Ki-67 del cáncer de mama deben ser fiables y objetivos.
  • Los médicos necesitan una valoración más fiable de ER/PGR/HER2/Ki-67 en los tejidos tumorales FFPE.
  • El 5 % de los resultados de HER2 por IHC son equívocos según las clasificaciones recomendadas por las directrices.1
  • Resolver los resultados equívocos de HER2 obtenidos por IHC2+ mediante FISH es difícil.1-4
  • La variabilidad técnica y del observador puede dar lugar a una inexactitud de aproximadamente un 20 % en los resultados de ER y PGR.5
  • Las puntuaciones de Ki-67 por IHC se desvían debido a la falta de estandarización.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.

La solución

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 permite la determinación semicuantitativa de los niveles de ARNm de ER/PGR/HER2/Ki-67 en cortes FFPE de cáncer de mama invasivo.
    • El gen de referencia CYFIP1* se utiliza para la estandarización de las muestras.
    • Se incluyen tres controles en cada ensayo.
    • El informe emitido por el software permite la interpretación sencilla y objetiva de los resultados.
CYFIP1: Proteína de interacción con FMR1 citoplasmático 1

El impacto

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.

Conéctese para obtener más información

Solicitar información

Perspectivas

Powered by Translations.com GlobalLink Web SoftwarePowered by GlobalLink Web