产品与服务

妈妈泰谱®

mRNA定量检测,为分型保驾护航

  • 首个NMPA认定的IVD进口创新产品
  • 首个国内上市的乳腺癌分子分型产品
  • 首个国内注册的mRNA多基因表达PCR产品

试剂盒规格

10测试/盒

注册证号

国械注进20233400600

推荐人群

  • IHC不易判定或结果不满意的患者
  • IHC结果与治疗预期有较大差别的患者

临床价值

  • 检测准确性与三位资深病理医生IHC判读一致结果相当
  • MKI67可靠检测,有效区分Luminal A/B型人群
  • PGR + LRP,实现Oncotype Dx®(原研21基因)低危人群初筛
  • 进一步明确ERBB2表达状态,辅助预后和治疗疗效判断

文献参考

1 Badr, N. M. et al. Concordance between ER, PR, Ki67, and HER2-low expression in breast cancer by MammaTyper RT-qPCR and immunohistochemistry: implications for the practising pathologist. Histopathology 85, 437-450, doi:10.1111/his.15193 (2024).

2 Schettini, F. et al. Prediction of response to neoadjuvant chemotherapy by MammaTyper(R) across breast cancer subtypes: A retrospective cross-sectional study. Breast 76, 103753, doi:10.1016/j.breast.2024.103753 (2024).

3 Finsterbusch, K., van Diest, P. J. & Focke, C. M. Intertumoral heterogeneity of bifocal breast cancer: a morphological and molecular study. Breast cancer research and treatment 205, 413-421, doi:10.1007/s10549-024-07281-2 (2024).

4 Baez-Navarro, X., van Bockstal, M. R., van der Made, A. & van Deurzen, C. H. M. A Comparison Between Immunohistochemistry and mRNA Expression to Identify Human Epidermal Growth Factor Receptor 2-Low Breast Cancer. Archives of pathology & laboratory medicine, doi:10.5858/arpa.2024-0255-OA (2024).

5 Caselli, E. et al. Looking for more reliable biomarkers in breast cancer: Comparison between routine methods and RT-qPCR. PloS one 16, e0255580, doi:10.1371/journal.pone.0255580 (2021).

6 Finsterbusch, K., Decker, T., van Diest, P. J. & Focke, C. M. Luminal A versus luminal B breast cancer: MammaTyper mRNA versus immunohistochemical subtyping with an emphasis on standardised Ki67 labelling-based or mitotic activity index-based proliferation assessment. Histopathology 76, 650-660, doi:10.1111/his.14048 (2020).

7 Varga, Z. et al. Ki-67 assessment in early breast cancer: SAKK28/12 validation study on the IBCSG VIII and IBCSG IX cohort. Scientific reports 9, 13534, doi:10.1038/s41598-019-49638-4 (2019).

8 Laible, M. et al. Impact of molecular subtypes on the prediction of distant recurrence in estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer upon five years of endocrine therapy. BMC cancer 19, 694, doi:10.1186/s12885-019-5890-z (2019).

9 Hartmann, K. et al. Robustness of biomarker determination in breast cancer by RT-qPCR: impact of tumor cell content, DCIS and non-neoplastic breast tissue. Diagnostic pathology 13, 83, doi:10.1186/s13000-018-0760-6 (2018).

10 Gurtler, C. et al. Transferring a Quantitative Molecular Diagnostic Test to Multiple Real-Time Quantitative PCR Platforms. The Journal of molecular diagnostics : JMD 20, 398-414, doi:10.1016/j.jmoldx.2018.02.004 (2018).

11 Sinn, H. P. et al. Comparison of immunohistochemistry with PCR for assessment of ER, PR, and Ki-67 and prediction of pathological complete response in breast cancer. BMC cancer 17, 124, doi:10.1186/s12885-017-3111-1 (2017).

12 Stefanovic, S. et al. Tumor biomarker conversion between primary and metastatic breast cancer: mRNA assessment and its concordance with immunohistochemistry. Oncotarget 8, 51416-51428, doi:10.18632/oncotarget.18006 (2017).

13 Varga, Z. et al. An international reproducibility study validating quantitative determination of ERBB2, ESR1, PGR, and MKI67 mRNA in breast cancer using MammaTyper(R). Breast cancer research : BCR 19, 55, doi:10.1186/s13058-017-0848-z (2017).

14 Stein, R. C. et al. OPTIMA prelim: a randomised feasibility study of personalised care in the treatment of women with early breast cancer. Health technology assessment 20, xxiii-xxix, 1-201, doi:10.3310/hta20100 (2016).

15 Laible, M. et al. Technical validation of an RT-qPCR in vitro diagnostic test system for the determination of breast cancer molecular subtypes by quantification of ERBB2, ESR1, PGR and MKI67 mRNA levels from formalin-fixed paraffin-embedded breast tumor specimens. BMC cancer 16, 398, doi:10.1186/s12885-016-2476-x (2016).

16 Wirtz, R. M. et al. Biological subtyping of early breast cancer: a study comparing RT-qPCR with immunohistochemistry. Breast cancer research and treatment 157, 437-446, doi:10.1007/s10549-016-3835-7 (2016).