QIAGEN launches first FDA-approved companion diagnostic for PIK3CA biomarkers to enhance precision medicine in breast cancer

Innovative therascreen® PIK3CA RGQ PCR Kit receives U.S. regulatory approval for use in guiding treatment decisions from tissue and liquid biopsy for newly approved therapy PIQRAY® (alpelisib) from Novartis

Germantown, Maryland, and Hilden, Germany, May 24, 2019 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the immediate launch of its therascreen® PIK3CA RGQ PCR Kit (therascreenPIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis.

The therascreenPIK3CA Kit is the first companion diagnostic assay to obtain premarket approval from the U.S. Food and Drug Administration (FDA) for use in any cancer indication for detection of activating mutations in the PIK3CA gene. It is also the first FDA approved assay for guiding treatment decisions in breast cancer using plasma specimens as a liquid biopsy. The assay detects 11 PIK3CA mutations, which are estimated to be present in approximately 40% of hormone receptor-positive (HR ) advanced or metastatic breast cancer patients. The real-time qualitative PCR kit is processed on QIAGEN’s Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions. The test leverages QIAGEN’s worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.

“We are very pleased to launch this innovative companion diagnostic in tandem with our partners at Novartis. This milestone further underscores our commitment to support patients with breast cancer. Each year, an estimated 66,500 patients in the United States are diagnosed with advanced or metastatic breast cancer. We are making the therascreen PIK3CA Kit available immediately following this FDA approval through leading laboratories in the U.S. as a result of QIAGEN’s Day-One Lab Readiness program for Precision Medicine,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “We are convinced that our new therascreen PIK3CA Kit, which expands our market-leading therascreen portfolio of companion diagnostics, and the approval of PIQRAY together provide a valuable treatment option for those searching for new ways to combat advanced breast cancer.”

QIAGEN’s therascreen PIK3CA Kit was co-developed in collaboration with Novartis and co-approved with PIQRAY (alpelisib) by the FDA. The Novartis drug is indicated in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Further detail about the Kit is available at www.qiagen.com/PIK3CA.

QIAGEN’s Day-One Lab Readiness program builds on the FDA’s modernized regulatory approach to benefit patients by accelerating the launch of advanced diagnostics. An updated list of U.S. laboratories offering the new therascreen PIK3CA test will be available at www.qiagen.com/PIK3CA-lab-finder.

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. Currently, 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. The therascreen PIK3CA Kit co-approval with PIQRAY marks the seventh FDA approval of a therapy with a QIAGEN companion diagnostic assay. QIAGEN will showcase its broad portfolio of companion diagnostics and other Sample to Insight solutions, including the novel therascreen PIK3CA Kit, at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting from May 31- June 4, 2019, in Chicago.


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 March 31, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found at www.qiagen.com.

Forward-Looking Statement

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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