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Qiagen, Therawis Partner to Develop Predictive Oncology Assays

NEW YORK (GenomeWeb) – Qiagen said on Wednesday that it has entered into a licensing and co-development agreement with Germany's Therawis Diagnostics in the area of predictive assays in oncology.

An initial project under the agreement will be to develop and market PITX2 as a marker to predict effectiveness of anthracycline treatment in triple negative and other high-risk breast cancer patients. PITX2 encodes for a protein called paired-like homeodomain transcription factor 2, which acts as a transcriptional regulator in basal and hormone-regulated activity of prolactin.

Under current clinical guidelines, the standard of care in high-risk breast cancer includes anthracycline-based chemotherapy, which produces a response rate of 50 percent or less in patients and has side effects including congestive heart failure and leukemia, Qiagen noted.

The PITX2 test is intended to predict which individuals will benefit from these chemotherapeutic drugs. It could enable clinicians to make decisions on whether to use standard drugs or provide other treatments to patients who are unlikely to benefit from anthracycline-based chemotherapy, Qiagen said. In addition, the PITX2 biomarker also has potential as a companion diagnostic to guide the use of targeted therapies under development, the company added. A Qiagen spokesperson also noted that test development will revolve around epigenetic modifications to PITX2.

Kai te Kaat, head of Qiagen's oncology franchise, said in a statement that Therawis has developed and achieved initial clinical validation of the PITX2 assay.

"The test addresses high unmet needs in breast cancer, the most common malignancy among women, and will add to our expanding portfolio that covers a range of sample-to-insight solutions to further advance personalized healthcare in this and other cancer indications," te Kaat said.