QIAGEN partners to develop predictive tests in oncology
Collaboration with Therawis addresses unmet need to guide clinical decisions in breast cancer
Hilden, Germany, and Germantown, Maryland, May 25, 2016 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today 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.
QIAGEN will demonstrate its Sample to Insight solutions for molecular diagnostic and research applications in oncology at Booth 18031 at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting on June 3-7, 2016, in Chicago. For more information on QIAGEN’s presence at ASCO please visit oncologysolutions.qiagen.com/ASCO.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2016, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
About Therawis Diagnostics
Therawis Diagnostics GmbH is a privately held oncology-focused company with offices located in Munich, Germany, and was founded together with clinicians and scientists of the Technical University of Munich in September 2015. Therawis Diagnostics GmbH develops and aims at to commercialize a comprehensive portfolio of predictive diagnostics to guide optimal therapy for cancer patients. Further information can be found at http://www.therawis.com.
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).