QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients

QIAGEN has announced a collaboration agreement with AstraZeneca PLC for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca’s targeted therapy for non-small cell lung cancer (NSCLC). The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca’s oral monotherapy anti-cancer treatment when tumor tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014.

The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study (IRESSA Follow-up Measure) presented at the “World Lung 2013” conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: “By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s diagnostic capabilities, we have the potential to transform the way specific tumor types are identified and treated. The use of circulating tumor DNA testing will allow doctors to target the individual needs of each patient quickly and accurately.”

“We are very pleased to collaborate with AstraZeneca in developing this new tool to improve life for lung cancer patients. This collaboration will further expand QIAGEN’s rapidly growing portfolio of liquid biopsy solutions for personalized healthcare which paves a path for patient monitoring using blood tests for future QIAGEN therascreen companion diagnostics. We are changing the treatment landscape with highly reliable genomic tests based on blood samples or other body fluids, providing physicians and patients with additional options to determine treatments and monitor progress,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “This new project with AstraZeneca under our master collaboration agreement, one of several such Pharma partnerships, adds to our expanding portfolio of reliable companion diagnostics which are creating valuable test content for the QIAsymphony family of automated instruments. As tests are developed, commercialization is accelerated through the established network of laboratories already using assays in QIAGEN’s industry-leading portfolio of companion diagnostics.”

IRESSA is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor that acts to block signals for cancer cell growth and survival. Certain EGFR gene mutations occur in a significant number of lung cancers, and these mutation-positive tumors are particularly sensitive to IRESSA. QIAGEN and AstraZeneca plan to develop a test that detects 21 EGFR mutations to identify patients most likely to benefit from the therapy, adapting QIAGEN technologies from the FDA-approved therascreen® EGFR RGQ PCR Kit. The new test kit is planned to run on QIAGEN's Rotor-Gene Q system, a member of the QIAsymphony family of automated instruments.

QIAGEN is at the forefront in developing and validating companion diagnostics to guide the selection of medicines in treating cancer and other diseases. In the United States, QIAGEN received FDA approvals in 2012 and 2014 for the therascreen® KRAS RGQ PCR Kit in colorectal cancer and in 2013 for the therascreen EGFR test in NSCLC. Last month, QIAGEN announced a collaboration with Lilly to develop companion diagnostics for simultaneous analysis of DNA and RNA biomarkers in common cancers. Earlier this year, QIAGEN entered into a collaboration with Exosome Diagnostics to develop first-in-class, non-invasive diagnostics for key genetic biomarkers in lung and other cancers. QIAGEN’s leading portfolio of liquid biopsy technologies also includes the QIAamp Circulating Nucleic Acid Kit, which is considered to be the gold standard sample technology for the processing of free circulating DNA and RNA, as well as the REPLI-g product line, which enables genomic analysis from single cells.