QIAGEN launches predictive therascreen PITX2 test in Europe to guide treatment in high-risk breast cancer
Feb 06 2018

QIAGEN launches predictive therascreen PITX2 test in Europe to guide treatment in high-risk breast cancer

Novel DNA methylation assay provides insights for individualized chemotherapy selection

Hilden, Germany, February 6th , 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the European launch of its novel therascreen PITX2 RGQ PCR Kit, the first clinically validated DNA methylation assay that helps predict the response of certain high-risk breast cancer patients to anthracycline-based chemotherapy. The CE-IVD marked assay is QIAGEN's first epigenetic test in breast cancer, as well as the latest addition to QIAGEN's broad portfolio of therascreen tests delivering individualized genetic insights to guide medical decisions in lung, colorectal and other cancers.

More than 460,000 women in Europe are newly diagnosed with breast cancer each year, with about 50% characterized as high-risk for disease recurrence. Anthracycline-based chemotherapy is the standard of care, yet not all patients benefit equally – and side effects can be as severe as congestive heart failure and leukemia. The therascreen PITX2 assay provides physicians and their patients a novel, independent criterion to augment clinical information used in selection of the most suitable therapy to treat certain high-risk breast cancer.

“We are very pleased to introduce this important test for Personalized Healthcare used to assess the best treatment approach for high-risk breast cancer patients. This reliable, clinically validated assay determines the PITX2 DNA methylation ratio to differentiate between patients who are more likely – or less likely – to show beneficial response to anthracyclines,” said Thierry Bernard, Senior Vice President, Molecular Diagnostics Business Area, for QIAGEN. “The simple workflow of the therascreen PITX2 assay provides automated processing from Sample to Insight in less than 48 hours. The test can easily be adopted by customers already running other therascreen assays on our widely used QIAsymphony automation platform.”

The therascreen PITX2 RGQ PCR Kit is a unique DNA methylation test which determines the percent methylation ratio (PMR) in promoter 2 of the pituitary homeobox transcription factor 2 (PITX2) gene as a novel biomarker. The clinical performance of the therascreen PITX2 assay 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-based 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. 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. This novel test is a great step forward for us clinicians to further optimize patient treatment”, commented Prof. Dr. Marion Kiechle, Chairman of the Department of Obstetrics & Gynecology and the Breast Cancer Center of The Technical University of Munich, Germany.

The assay is processed on QIAGEN's Rotor-Gene Q MDx real-time cycler, part of the QIAsymphony family of instruments, with automated analysis and calculation of the PITX2 percent methylation ratio using the Rotor-Gene AssayManager software. The simple, fast workflow from FFPE tissue samples to the PITX2 PMR as an easy readout can deliver multiple clinical results in less than two working days.

The therascreen PITX2 assay has been developed as part of a licensing and co-development agreement signed in 2016 between QIAGEN and Therawis Diagnostics GmbH, an oncology-focused company founded by clinicians and scientists at the Technical University of Munich. The therascreen PITX2 assay is the initial project in that collaboration.

About QIAGEN

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 (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2017, QIAGEN employed approximately 4,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.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).

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