Breast cancer epigenetic diagnostics
Therascreen PITX2 breast cancer epigenetic test
The kit enables the determination of the percent methylation ratio (PMR) in promoter 2 of the PITX2 gene. This PMR value of PITX2 promotor 2 is predictive of the response to anthracycline-based chemotherapy regimes in lymph node-positive, estrogen receptor-positive and HER2-negative high-risk breast cancer patients. Applying PITX2 methylation as a predictive biomarker can help clinicians to select the appropriate chemotherapy regimen.
To ensure reliable and sensitive determination of the PITX2 promoter 2 methylation status, the therascreen kit has been optimized to detect and differentiate between a methylated and unmethylated state in the target region of the PITX2 promoter 2. For samples with a low PMR, the limit of detection (LOD) is 4 and for samples with a high PMR the upper detection limit is 92, facilitating a highly reliable determination of PMR values in the range in-between. Additionally, the assay has a wide range of linearity, from PMR 5 to 50. The clinical validity of the pre-defined PMR cut-off of 12 to predict patient response to anthracycline-based chemotherapy with or without endocrine therapy was shown by using 145 patient samples with 10-year follow-up data and disease-free survival as the primary end point.
