Qiagen NV, Hilden, Germany, has entered into a licensing and codevelopment agreement with Therawis Diagnostics GmbH, Germantown, Md, to develop and commercialize predictive assays in oncology. An initial project will be to develop and market PITX2 as a marker to predict the effectiveness of anthracycline treatment in triple-negative and other high-risk breast cancer patients.

Kai te Kaat, Qiagen.

Kai te Kaat, PhD, Qiagen.

“We are pleased to partner with Therawis, which developed the PITX2 assay and achieved initial clinical validation,” says Kai te Kaat, PhD, head of the oncology franchise at Qiagen. “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.”

Olaf G. Wilhelm, MD, Therawis.

Olaf G. Wilhelm, MD, Therawis.

“Partnering with Qiagen will make our PITX2 test widely available in standardized workflows for routine diagnostics and to benefit breast cancer patients globally,” says Olaf G. Wilhelm, MD, cofounder and chief executive of Therawis. “We look forward to codeveloping and commercializing additional tests. Therawis is uniquely focused on bringing to market predictive diagnostics to guide the optimal therapy for breast cancer patients.”

Under current clinical guidelines, the standard of care for high-risk breast cancer includes anthracycline-based chemotherapy, which produces a response rate of 50% or less in patients and has side effects that can be as severe as congestive heart failure or leukemia. The PITX2 test licensed by Qiagen predicts which individuals will benefit from these chemotherapeutic drugs. It could enable clinicians to decide whether to use standard drugs or provide other treatments to patients who are unlikely to benefit from anthracycline-based chemotherapy. The PITX2 biomarker also has potential value as a companion diagnostic to guide the use of novel targeted therapies under development.

About 1.7 million new breast cancer cases are reported each year, making it the most common cancer among women and second-most common overall, according to the World Health Organization. Annual deaths due to breast cancer are estimated at more than 500,000. As with other cancers, the disease varies greatly among individuals, as do outcomes, based on many different factors.

For more information, visit Qiagen or Therawis Diagnostics.