QIAGEN has announced that the company has entered into a licensing and co-development agreement with Therawis Diagnostics GmbH to develop and commercialize predictive assays in oncology. An initial project 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.
“We are pleased to partner with Therawis, which developed the PITX2 assay and achieved initial clinical validation”, said Kai te Kaat, Head of QIAGEN’s Oncology Franchise. “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.”
Prof. Dr. med. Olaf G. Wilhelm, co-founder and Chief Executive Officer of Therawis, an oncology-focused company founded by clinicians and scientists at the Technical University of Munich commented: “Partnering with QIAGEN will make our PITX2 test widely available in standardized workflows for routine diagnostics and to benefit breast cancer patients globally. We look forward to co-developing 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 in 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 potentially 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. The PITX2 biomarker also has potential value for 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 (WHO). 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 example, triple-negative breast cancer (TNBC) makes up about 15% of cases, about 120,000 a year in Europe and the U.S., with a poor prognosis and low overall survival rate. The standard of care for TNBC is a core biopsy, neo adjuvant anthracycline-based chemotherapy followed by surgery. Only about 35% of TNBC patients respond to the chemotherapy, and 65% do not. So the value of a reliable predictive test to guide treatment decisions would be significant. To date, the PITX2 biomarker has demonstrated unprecedented predictive value in triple-negative and other high-risk breast cancers.