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AstraZeneca PLC said Monday it is working with Roche Holding AG and QIAGEN NV to develop companion diagnostic tests to support its portfolio of lung cancer medicines.
IRESSA is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that blocks the signals from the EGFR, which leads to tumour growth. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, particularly non-small cell lung cancer (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 tumour tissue by needle biopsy or during resection.
QIAGEN’s test uses a highly sensitive assay to detect EGFR mutations in the small fragments of circulating tumour DNA (ctDNA) in plasma taken from patients’ blood samples. The test has demonstrated robust and reliable identification of EGFR mutation status using samples from the Phase IV IRESSA Follow Up Measure (IFUM) study.
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.
Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: “By combining AstraZeneca’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 excited about this new partnership with AstraZeneca”, said Peer M. Schatz, CEO of QIAGEN. “Liquid biopsies are an exciting new field in sample technology and an area of core leadership for QIAGEN. We are rapidly expanding our portfolio in this field and are seeing a broad uptake of our new standards. Our novel solutions for processing tumor DNA and RNA from body fluids are being widely validated for clinical use with existing and new assays and have the potential to improve outcomes for patients for whom invasive surgery is not an option.”
Agencies/Canadajournal
