QIAGEN launches therascreen BRAF test as companion diagnostic to a BRAFTOVI® (encorafenib) based regimen in metastatic colorectal cancer
• U.S. FDA approves therascreen BRAF V600E RGQ PCR assay as companion diagnostic
• Test will help identify patients eligible for treatment with the BRAF inhibitor, BRAFTOVI, which the FDA has approved for use in combination with ERBITUX® (cetuximab) in adults with previously treated metastatic colorectal cancer with a BRAF V600E mutation
Germantown, Maryland, and Hilden, Germany, April 15 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced launch of its novel therascreen® BRAF V600E RGQ PCR Kit (therascreen BRAF V600E Kit) following U.S. Food and Drug Administration (FDA) approval as a companion diagnostic to the BRAF inhibitor, BRAFTOVI® (encorafenib), which the FDA has approved for use in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Colorectal cancer is the third most common type of cancer, and approximately 150,000 patients a year in the United States are diagnosed with CRC. In primary and metastatic CRC, BRAF mutations (nearly always V600E) are present in up to 15% of patients and are thought to be key drivers of tumor growth. Detection of the V600E mutation utilizing the therascreen BRAF V600E assays will help identify patients eligible for treatment with the newly approved combination of BRAFTOVI and cetuximab. The therascreen BRAF V600E kit runs on QIAGEN’s Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions.
“We are very excited about the launch of the new therascreen BRAF V600E Kit, our first companion diagnostic test to obtain FDA approval for the detection of a mutation in the BRAF gene and our third CDx approval in colorectal cancer. Using our new test to help guide treatment decisions in colorectal cancer will address a high unmet medical need among patients,” said Jonathan Arnold, Vice President and Head of Partnering for Precision Diagnostics at QIAGEN. “The new therascreen BRAF V600E Kit will be available to accelerate the availability of innovations in precision medicine.”
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 recent therascreen BRAF V600E approval marks the 8th FDA approval of a therapy with a QIAGEN companion diagnostic assay.
For more information on QIAGEN’s companion diagnostics please visit www.qiagen.com/braf
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 December 31, 2019, QIAGEN employed approximately 5,100 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, 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 QFT-Plus test for latent TB, its portfolio of next generation sequencing solutions and QIAstat-Dx), net sales in particular geographies, adjusted net sales, adjusted diluted earnings per share results, product launches (including anticipated launches of next generation sequencing solutions, the QIAstat- Dx syndromic testing platform, a gastrointestinal panel in the U.S., and a CE-IVD marked panel for meningitis), development of tissue-based companion diagnostics for Amgen’s investigational new oncology therapy, placements of QIAsymphony modular PCR instruments, improvements in operating and financial leverage, currency movements against the U.S. dollar, plans for investment in its portfolio and share repurchase commitments, plans to shift our Global Operations organization to a regional manufacturing structure, our ability to grow adjusted earnings per share at a greater rate than sales, our ability to improve operating efficiencies and maintain disciplined capital allocation, and plans to take further pre-tax charges in 2020 related to the project announced in Q3 2019, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, or other force majeure events; 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).
*Pfizer Inc. has exclusive right to BRAFTOVI® in the U.S. and Canada.
**Erbitux® is a registered trademark of ImClone LLC.