Qiagen, a Netherlands-based holding company, has announced a collaboration agreement with AstraZeneca for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AZ'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 AZ'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 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), 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, "The use of circulating tumor DNA testing will allow doctors to target the individual needs of each patient quickly and accurately."