QIAGEN Companion Diagnostic Wins FDA Approval for use with IRESSA

QIAGEN N.V. today received U.S. marketing (PMA) approval of its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) as a companion diagnostic to guide the use of AstraZeneca’s IRESSA® (gefitinib) in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). QIAGEN’s therascreen EGFR test was approved by the Food and Drug Administration to enable doctors to identify NSCLC patients who have tumors that are positive for epidermal growth factor receptor (EGFR) mutations and therefore are eligible for treatment with AstraZeneca’s drug.

More than 200,000 new lung cancer cases are diagnosed every year in the United States, with NSCLC accounting for approximately 85% of cases, leading to an estimated 160,000 deaths. Testing for EGFR mutations is believed to be the largest segment in companion diagnostics for personalized medicine

“We are very pleased to offer the therascreen EGFR test in the United States to guide the use of IRESSA, a further milestone in personalized medicine for lung cancer patients. QIAGEN's leadership in companion diagnostics continues to grow, transforming patient care around the world,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area and a member of the Executive Committee of QIAGEN. “The FDA approval of our therascreen EGFR test with IRESSA is another highlight in QIAGEN’s ongoing, successful collaboration with AstraZeneca. This marks QIAGEN’s fourth U.S. approval of a companion diagnostic. As the second FDA-approved use of therascreen EGFR in NSCLC, the pairing with IRESSA also expands QIAGEN’s U.S. market leadership in EGFR testing. Our growing Personalized Healthcare portfolio continues to broaden the content menu for Rotor-Gene Q, a member of our QIAsymphony platform family.”

“We are delighted to be partnering with QIAGEN to provide this important companion diagnostic test to guide the use of IRESSA for patients with NSCLC in the U.S. By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s leading diagnostic technologies, we have the potential to help physicians achieve better patient outcomes in NSCLC”, said Ruth March, Vice President and Head of Personalized Healthcare and Biomarkers at AstraZeneca.

Along with the therascreen EGFR test to analyze tissue from lung tumors, the FDA approved IRESSA for first line treatment of NSCLC in patients identified with the aid of an FDA-approved companion diagnostic. QIAGEN and AstraZeneca have a long-term global collaboration for co-development and co-commercialization of companion diagnostics. IRESSA is now marketed in more than 90 countries, and QIAGEN offers companion diagnostics in more than 60 countries. In January 2015, QIAGEN launched the therascreen EGFR Plasma RGQ PCR Kit* in more than 30 European countries, a CE-IVD marked test co-developed with AstraZeneca. The plasma kit analyzes EGFR mutation status from blood and is the first-ever “liquid biopsy” regulatory registration of a companion diagnostic to benefit solid-tumor patients for whom surgical biopsies are not assessable. QIAGEN also is engaged in additional partnerships focusing on companion diagnostics for use with third-generation tyrosine kinase inhibitors targeting EGFR in NSCLC and has developed tests for other biomarkers targeting NSCLC, including ALK and KRAS.

In the United States, the therascreen EGFR RGQ PCR Kit has been marketed since 2013 as a companion diagnostic for another drug used in NSCLC patients. According to industry reports, QIAGEN provides approximately 50% of companion diagnostic kits targeting EGFR mutations, making the therascreen EGFR test the U.S. commercial leader by a substantial margin.

Globally, QIAGEN is at the forefront in developing companion diagnostics to guide the selection of medicines for cancer and other diseases. The company already markets Personalized Healthcare kits covering about 30 biomarkers, spanning a range of automation platforms and sample types, around the world. QIAGEN continues to expand its pipeline of Sample to Insight technologies for personalized healthcare applications and intends to submit more tests for regulatory clearance or approval. The company has more than 15 projects with leading pharmaceutical and biotech companies to co-develop and market companion diagnostics. In addition, QIAGEN is developing a pipeline of liquid biopsy-based tests for research and eventual use in clinical diagnostics.

The therascreen EGFR test has been developed by QIAGEN Manchester, the global center for the development and regulatory approval of QIAGEN’s molecular diagnostic applications.