Skip to main content
Premium Trial:

Request an Annual Quote

Qiagen Garners CE Mark for PITX2 Test to Guide Breast Cancer Treatment

NEW YORK (GenomeWeb) – Qiagen said on Tuesday that it has received CE-IVD marking for its Therascreen PITX2 RGQ PCR kit and launched the assay in Europe.

The new kit is a methylation assay intended to help predict the response of certain high-risk breast cancer patients to anthracycline-based chemotherapy. It runs on Qiagen's Rotor-Gene Q MDx real-time thermal cycler and can easily be adopted by customers already running Therascreen assays on the company's QIAsymphony automation platform.

The assay determines the percent methylation ratio (PMR) in promoter 2 of the pituitary homeobox transcription factor 2 gene as a biomarker. Its clinical performance was evaluated in a retrospective clinical study in lymph node-positive, estrogen receptor-positive and HER2-negative high-risk breast cancer patients treated with anthracycline chemotherapy. Patients with low PMRs demonstrated increased disease-free survival, applying 10-year follow-up as the primary study endpoint.

"We have several treatment options for high-risk breast cancer patients, and standard of care is anthracycline-based chemotherapy," Marion Kiechle, chairman of the Department of Obstetrics and Gynecology and the Breast Cancer Center of The Technical University of Munich, said in a statement.

"For the first time, the determination of PITX2 DNA methylation provides an excellent diagnostic tool to identify those patients who will benefit, and those who have a lower probability of benefitting," Kiechle added. "This novel test is a great step forward for us clinicians to further optimize patient treatment."

The assay was developed as part of a licensing and co-development agreement signed in 2016 between Qiagen and Therawis Diagnostics.