QIAGEN receives approval for EGFR test in lung cancer as companion diagnostic in Japan

PMDA allows use of therascreen® EGFR RGQ PCR Kit for targeted treatment with Pfizer's VIZIMPRO® (dacomitinib) in patients with non-small cell lung cancer

(PresseBox) ( Hilden, Germany / Tokyo, Japan, )
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the Japanese Pharmaceuticals and Medical Device Agency (PMDA) has approved the therascreen® EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO® (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer. The therascreen® EGFR RGQ PCR Kit is registered in more than 40 countries globally. This marks the first companion diagnostic approval for QIAGEN in Japan.

“As precision medicine becomes the standard of care in oncology, we are pleased to provide benefits to more lung cancer patients with our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Pfizer has made great strides already and will continue to improve personalized healthcare for patients around the world,” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics for QIAGEN. “In addition to detecting a comprehensive panel of EGFR mutations, the therascreen EGFR kit offers laboratories an efficient workflow on the Rotor-Gene Q MDx, the real-time PCR module in our widely-used QIAsymphony family of instruments.”

QIAGEN is a pioneer in Personalized Healthcare and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect 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 has been the market leader in companion diagnostics working under master collaboration agreements with more than 25 pharmaceutical companies developing companion diagnostic tests for their drug candidates. For more details surrounding QIAGEN’s companion diagnostics and their claims please visit www.qiagen.com. For additional information on Pfizer’s VIZIMPRO® (dacomitinib) please visit www.pfizer.com.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer deaths worldwide, and non-small cell lung cancer (NSCLC) accounts for an estimated 80-85 percent of cases. NSCLC remains difficult to treat, particularly because many patients are diagnosed with advanced or metastatic disease, where the five-year survival rate is only five percent. Mutations in the EGFR gene, generally somatic changes that develop during a patient’s lifetime rather than through inheritance, are implicated in an estimated 10-35 percent of NSCLC cases globally. Cancers with these mutations tend to respond to treatments that specifically target the overactive EGFR protein that causes cancer cells to constantly grow and divide.

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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