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Qiagen, AstraZeneca Reach CDx Deal for NSCLC

NEW YORK (GenomeWeb) – Qiagen today announced a collaborative deal with AstraZeneca to develop a liquid biopsy-based companion diagnostic for the drugmaker's targeted non-small cell lung cancer therapy Iressa (gefitinib).

The assay will analyze plasma samples to evaluate EGFR mutation status in patients with NSCLC to help guide the treatment of patients with Iressa when tumor tissue is not available. Qiagen noted that its tissue-based companion diagnostic, the therascreen EGFR RGQ PCR kit, was approved by the US Food and Drug Administration last year and by regulators in China in May.

The deal builds on a master agreement between Qiagen and AstraZeneca reached in 2013. The companies plan to develop a test to detect 21 EGFR mutations to identify those patients most likely to benefit from Iressa, an epidermal growth factor receptor-tyrosine kinase inhibitor that blocks signals for cancer cell growth and survival. The new kit will run on Qiagen's Rotor-Gene Q system.

"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," Mondher Mahjoubi, VP of global product strategy for oncology at AstraZeneca, said in a statement. "The use of circulating tumor DNA testing will allow doctors to target the individual needs of each patient quickly and accurately."

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