AP NEWS

QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Lung Cancer

September 28, 2018

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--Sep 28, 2018--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA Supplement expanding the labelling claim of the therascreen® EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO ® (dacomitinib) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 L858R mutation. The therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also GILOTRIF ® (Afatinib) from Boehringer Ingelheim and Iressa ® (Gefitinib) from AstraZeneca. It is registered in more than 40 countries globally. This was a project governed under an agreement between QIAGEN and Pfizer.

“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.”

Please find the full press release here

View source version on businesswire.com:https://www.businesswire.com/news/home/20180927006044/en/

CONTACT: QIAGEN

Investor Relations

John Gilardi, +49 2103 29 11711

Dr. Sarah Fakih, +49 2103 29 11457

e-mail:ir@QIAGEN.com

or

Public Relations

Dr. Thomas Theuringer, +49 2103 29 11826

Robert Reitze, +49 2103 29 11676

e-mail:pr@QIAGEN.com

KEYWORD: AUSTRIA UNITED STATES EUROPE NORTH AMERICA MARYLAND GERMANY SWITZERLAND

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY MEDICAL DEVICES ONCOLOGY PHARMACEUTICAL

SOURCE: QIAGEN N.V.

Copyright Business Wire 2018.

PUB: 09/28/2018 02:30 AM/DISC: 09/28/2018 02:30 AM

http://www.businesswire.com/news/home/20180927006044/en

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