A study recently demonstrated promising results using the MammaTyper in vitro diagnostic test from BioNTech Diagnostics GmbH, Mainz, Germany, a subsidiary of BioNTech AG, when compared to immunohistochemical (IHC) detection methods.1

Results of the gene expression analysis with MammaTyper were compared with results of manual microscopic analysis of IHC specimens, as well as with computer-assisted image analysis.

In accordance with previous studies, MammaTyper demonstrated better quantitative determination of the proliferation marker MKI67 (Ki-67) compared to IHC. The test achieved significantly higher specificity than IHC in the identification of a possible pathological complete remission after neoadjuvant therapy.

The study used formalin-fixed, paraffin-embedded (FFPE) routine biopsy samples from breast cancer patients who had participated in a randomized neoadjuvant study.2 Samples were analyzed with the three methods prospectively and retrospectively.

“The study demonstrates that MammaTyper is able to reliably prognosticate tumor proliferation activity and the response to neoadjuvant therapy,” says Hans-Peter Sinn, MD, PhD, a professor at the University of Heidelberg and head of the study. “That means patients may be spared unnecessary treatments.”

Results of the determination of biomarkers ESR1 (ER) and PGR (PR) confirmed a correlation of MammaTyper with IHC results, showing a slightly higher correlation of MammaTyper and computer-assisted IHC (ER/ESR1: 91.23 %, p<0.0001; PR/PGR: 92.9 %, p < 0.0001).

In contrast, MammaTyper and computer-assisted IHC image analysis achieved, as expected, moderate correlation (Spearman’s r = 0.5; p = 0.0001) in the detection of the proliferation marker MKI67 (Ki-67). However, correlated with clinical progress data, MammaTyper was shown to be more effective than IHC in predicting the response to neoadjuvant therapy derived from MKI67 determination.

For more information, visit BioNTech Diagnostics.

REFERENCES

  1. Sinn HP, Schneeweiss A, Keller M, 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. 2017;17(1):124; doi: 10.1186/s12885-017-3111-1.
  1. Schneeweiss A, Marme F, Ruiz A, et al. A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer. Ann Oncol. 2011;22(3): 609–617; doi: 1093/annonc/mdq400.