QIAGEN launches first FDA-approved companion diagnostic using FGFR alterations to help guide the treatment of metastatic urothelial cancer
Novel therascreen® FGFR RGQ RT-PCR Kit will aid in identifying patients eligible for treatment with BALVERSA™ (erdafitinib), developed by Janssen
Germantown, Maryland, and Hilden, Germany, April 12 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of its novel therascreen® FGFR RGQ RT-PCR Kit (therascreen FGFR Kit) as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA™ (erdafitinib), developed by Janssen Biotech, Inc. (Janssen). The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 (FGFR3) gene. The U.S. Food and Drug Administration co-approved the new test with BALVERSA™, as announced today by Janssen.
Urothelial cancer begins in tissues lining the bladder and other genitourinary organs and is the sixth most common type of cancer in the United States. An estimated 15,000 patients a year in the United States are diagnosed with advanced or metastatic urothelial cancer, but current treatment options are limited so the prognosis is poor. A percentage of urothelial carcinoma tumors have certain FGFR alterations which are thought to be key drivers of tumor growth. Detection of these alterations utilizing the companion diagnostic will help identify patients eligible for treatment with BALVERSA. The therascreen FGFR Kit will run on QIAGEN’s Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions and leverages a worldwide exclusive license for in-vitro diagnostic use of FGFR3:TACC3 fusions from Columbia University.
“We are very excited about the launch of the new therascreen FGFR Kit, the first companion diagnostic test to obtain FDA approval for detection of FGFR gene alterations to guide therapy in any cancer indication. Using our test to help guide treatment decisions in urothelial cancer will address a high unmet medical need among patients,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “The new therascreen FGFR Kit and significant testing capacities at leading laboratories will be available through QIAGEN’s Day-One Lab Readiness program to accelerate the availability of innovations in Precision Medicine.”
An updated list of laboratories offering the new therascreen FGFR Kit under QIAGEN’s Day-One Lab Readiness program is available on QIAGEN’s FGFR lab finder web page (www.qiagen.com/fgfr-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 on the use of drugs in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from NGS to PCR for companion diagnostic development and is currently working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates. The therascreen FGFR Kit co-approval with BALVERSA marks the sixth FDA approval of a therapy with a QIAGEN companion diagnostic assay. For more information on QIAGEN’s companion diagnostics please visit www.qiagen.com.
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, 2018, QIAGEN employed approximately 5,000 people in over 35 locations worldwide.
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 sales, adjusted net sales and adjusted diluted earnings per share 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; 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).
BALVERSA is a trademark of Janssen Biotech, Inc.