QIAGEN launches FFPE and Liquid Biopsy PIK3CA diagnostics in Europe to enhance precision medicine in advanced breast cancer
• Innovative therascreen® PIK3CA RGQ PCR Kit CE-marked for use in guiding treatment decisions for breast cancer patients
• Test detects activating mutations in the phosphatidylinositol3-kinase catalytic subunit alpha (PIK3CA) gene
• CE-IVD approved therascreen assay will be available to labs in Europe starting immediately
Germantown, Maryland, and Hilden, Germany, February 3, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the CE-marking and launch of its therascreen® PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation. Last year the therascreen PIK3CA test was approved by the FDA and launched as a companion diagnostic test for Piqray® (alpelisib) in the US.
The therascreen PIK3CA test is a new diagnostic assay for detection of activating mutations in the phosphatidylinositol3-kinase catalytic subunit alpha (PIK3CA) gene, and the first to enable testing of both DNA from FFPE tissue or plasma specimens. All QIAGEN therascreen PIK3CA tests leverage QIAGEN’s worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on detection of mutations in the PIK3CA gene.
1 in 8 women in Europe will develop breast cancer before the age of 85, making it the most common form of cancer in female patients. The therascreen assay detects 11 clinically actionable PIK3CA mutations, which are estimated to be present in approximately 40% of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+ HER2-) advanced breast cancer cases.
“This launch in Europe further underscores our commitment to support patients with breast cancer, the most common cancer in female cancer patients, with an estimated incidence of 562,500 in Europe in 2018 according to the WHO” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics. “We are convinced that our therascreen PIK3CA Kit, which expands our market-leading therascreen portfolio of companion diagnostics, will provide a valuable testing option for those seeking new ways to combat advanced breast cancer. We are committed to making the therascreen PIK3CA Kit available immediately so that leading laboratories in Europe can provide patients with the test as soon as possible.”
QIAGEN’s PIK3CA test was co-developed in collaboration with Novartis as a companion diagnostic for Piqray® in the United States. This real-time qualitative PCR test is performed using QIAGEN’s Rotor-Gene Q MDx instruments, which are members of the modular QIAsymphony family of automation solutions. The assay workflow also utilizes QIAGEN’s market leading QIAamp in-vitro diagnostic DNA sample preparation kits for FFPE tissue and plasma. Together with the PIK3CA test kit, the QIAamp DSP Circulating Nucleic Acid kit has now also been CE-marked and launched for use in liquid biopsy diagnostic procedures which analyze nucleic acid samples isolated from blood plasma specimens.
Additional information can be found at http://www.qiagen.com/PIK3CA-CE
QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies for co-development of companion diagnostics, which detect clinically relevant genetic abnormalities and provide the molecular insights that guide clinical decision making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of expertise in molecular diagnostic technologies for companion diagnostic development, ranging from next-generation sequencing (NGS) to polymerase chain reaction (PCR). QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients around the world.
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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2019, QIAGEN employed approximately 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Piqray® is a registered trademark of Novartis AG.
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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected net sales, net sales of particular products (including anticipated sales of its QuantiFERON latent TB Test, its portfolio of next generation sequencing solutions and QIAstat-Dx), adjusted net sales, adjusted diluted earnings per share results, product launches (including anticipated launches of digital PCR products, a new version of its QuantiFERON-TB test, QuantiFERON-TB Access, the QIAstat-Dx panel for respiratory conditions and a CE-IVD marked panel for meningitis), placements of QIAsymphony modular PCR instruments, improvements in operating and financial leverage, currency movements against the U.S. dollar, and plans for investment in its portfolio and share repurchase commitments, 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; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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).