Products

therascreen® PITX2 RGQ PCR Kit

The therascreen®PITX2 RGQ PCR Kit has been developed by therawis diagnostics together with its partner QIAGEN. The therascreen® PITX2 RGQ PCR Kit is CE-certified and commercially available.

The therascreen® PITX2 RGQ PCR Kit a unique DNA methylation test for determination of the percent methylation ratio (PMR) in promoter 2 of the pituitary homeobox transcription factor 2 (PITX2) gene using methylation specific real-time PCR on the Rotor-Gene Q 5-plex HRM instrument. The kit provides reagents optimized for reliable and sensitive determination of the PITX2 methylation status and allows for a clinically validated determination of the PMR cut-off value of 12, which is predictive for the response to adjuvant anthracycline-based chemotherapy with or without endocrine therapy when used to test formalin-fixed, paraffin-embedded (FFPE) tissue samples from lymph node-positive, hormonereceptor-positive and HER2-negative high-risk breast cancer patients.

Key features of the therascreen® PITX2 RGQ PCR Kit are:

  • Clinically validated CE-certified IVD according to EU Directive 98/79/ECon in vitro diagnostic medical devices
  • Robust and reliable, independent of tumor content
  • Simple and efficient workflow with Ready-to-use solutions and reaction mixes
  • Sample to Insight within <48 hours
  • Automated software using Rotor-Gene AssayManager v2.1 for quick and easy results interpretation

The therascreen® PITX2 RGQ PCR kit is intended for the determination of the percent methylation ratio (PMR) of bisDNA bisulfite converted gDNA extracted from FFPE tissue from high risk breast cancer patients. This PMR will aid the clinicians in the prediction of the response to (neo-)adjuvant anthracycline-based chemotherapy (ANT) in high risk breast cancer patients. 

Press Releases

therawis diagnostics' licensing and development partner QIAGEN launches predictive therascreen PITX2 test in Europe to guide treatment in high-risk breast cancer.

Read Press Release
February 7, 2018

therawis diagnostics and QIAGEN enter into a development and commercialization agreement on predictive biomarkers in oncology.

Read Press Release
May 26, 2016

Clinical validation publications

1

Napieralski R, Schricker G, Auer G, Aubele M, Perkins J, Magdolen V, Ulm K, Hamann M, Walch A, Weichert W, Kiechle M, Wilhelm OG.PITX2 DNA-Methylation: Predictive versus Prognostic Value for Anthracycline-Based Chemotherapy in Triple-Negative Breast Cancer Patients. Breast Care
(Basel). 2021 Oct;16(5):523-531. doi: 10.1159/000510468.

2

Napieralski R, Schricker G, Schueren E, Perkins J, Magdolen V, Weichert W, Kiechle M, Wilhelm O: Establishment of a RESEARCH USE ONLY Condensed-Efficient-Fast (CEF) PITX2 workflow for analysis of PITX2 DNA methylation in small tumor tissue samples. Protocol Exchange 2020.

3

Napieralski R, Schricker G, Auer G, Aubele M, Perkins J, Magdolen V, Ulm K, Hamann M, Walch A, Weichert W, Kiechle M and Wilhelm OG. PITX2 DNA-methylation: predictive versus prognostic value for anthracycline-based chemotherapy in triple-negative breast cancer patients. Accepted for publication in Breast Care 2020.

4

Schricker G, Napieralski R, Noske A, Piednoir E, Manner O, Schuren E, Lauber J, Perkins J, Magdolen V, Schmitt M, Ulm K, Weichert W, Kiechle M, Martens JWM, Wilhelm OG: Clinical performance of an analytically validated assay in comparison to microarray technology to assess PITX2 DNA-methylation in breast cancer. Sci Rep 2018;8:16861

5

Schmitt M, Wilhelm OG, Noske A, Schricker G, Napieralski R, Vetter M, Aubele M, Perkins J, Lauber J, Ulm K, Thomssen C, Martens JWM, Weichert W, Kiechle M: Clinical Validation of PITX2 DNA Methylation to Predict Outcome in High-Risk Breast Cancer Patients Treated with Anthracycline-Based Chemotherapy. Breast Care (Basel) 2018;13:425-433.

6

Schmitt M, Wilhelm OG, Noske A, Schricker G, Napieralski R, Vetter M, Aubele M, Perkins J, Lauber J, Ulm K, Thomssen C, Martens JWM, Weichert W, Kiechle M: Clinical Validation of PITX2 DNA Methylation to Predict Outcome in High-Risk Breast Cancer Patients Treated with Anthracycline-Based Chemotherapy. Breast Care (Basel) 2018;13:425-433.

Our Products

Stratgic investors and partners