October 2014—AstraZeneca announced it has entered into 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. The companion diagnostic test is designed to identify epidermal growth factor receptor 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.
“This collaboration will enable molecular testing through plasma specimens and provide the information needed to inform treatment decisions without the complications of surgery, consequently increasing the level of care clinicians can give to the patient,” Paul Brown, head of Roche Molecular Diagnostics, said in a statement.
The company also announced it has entered into a collaboration with Qiagen to develop a noninvasive diagnostic test to identify non-small cell lung patients who are suitable for treatment with IRESSA. Using Qiagen’s diagnostic test, doctors will be able to identify patients with the EGFR mutation, and therefore identify those patients who might benefit most from treatment with IRESSA, through a blood test.
Qiagen’s test uses a highly sensitive assay to detect EGFR mutations in the small fragments of circulating tumor DNA in plasma taken from patients’ blood samples. The test has demonstrated robust and reliable identification of EGFR mutation status using samples from the phase four IRESSA Follow Up Measure study.
The two companies are seeking approval from the European Medicines Agency for the ctDNA test, as a companion diagnostic for IRESSA.