AstraZeneca has formed a collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca's investigational compound in clinical development for non-small-cell lung cancer (NSCLC).

The companion diagnostic test is designed to identify epidermal growth factor receptor (EGFR) mutations in both tumor tissue and plasma derived from patients with NSCLC and to optimize the clinical development of AZD9291 for patients who are resistant to first-generation EGFR tyrosine kinase inhibitors (TKI).

Currently, patients who have been treated with EGFR-TKIs in whom the disease has progressed have to undergo a repeat biopsy to assess whether they have a specific mutation, T790M. Diagnostic tests based on circulating DNA (ctDNA) in plasma samples provide an alternative method of identifying the T790M mutation.

In a separate deal, AstraZeneca has entered into a collaboration with Netherlands-based Qiagen to develop a non-invasive diagnostic test to identify NSCLC patients who are suitable for treatment with AstraZeneca’s Iressa (gefitinib),

Iressa is an EGFR-TKI that blocks the signals from the EGFR, which leads to tumor growth. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, NSCLC cells. Using Qiagen’s diagnostic test, doctors will be able to identify patients with the EGFR mutation, and therefore who might benefit most from treatment with Iressa through a blood test. Currently, the main method of assessing EGFR mutation status involves the collection of tumor tissue by needle biopsy or during resection.

This collaboration is part of a long standing relationship between AstraZeneca and Qiagen. The two companies are seeking approval from the European Medicines Agency for the ctDNA test, as a companion diagnostic for Iressa.

Source: AstraZeneca (Roche collaboration) and AstraZeneca (Qiagen collaboration)