Qiagen and AstraZeneca collaborate to develop liquid biopsy-based companion diagnostic

Qiagen has announced a collaboration agreement with AstraZeneca (AZ) for the co-development and commercialisation 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 analyses 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 tumour 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 US by 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, SVP, global product strategy for oncology at AZ, said: "By combining AZ's expertise in lung cancer with Qiagen's diagnostic capabilities, we have the potential to transform the way specific tumour types are identified and treated. The use of circulating tumour DNA testing will allow doctors to target the individual needs of each patient quickly and accurately."

"We are very pleased to collaborate with AZ 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 personalised 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, CEO of Qiagen. "This new project with AZ 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, commercialisation is accelerated through the established network of laboratories already using assays in Qiagen's industry-leading portfolio of companion diagnostics."