UK-based AstraZeneca has entered into collaboration with Netherlands-based Qiagen to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
IRESSA works by blocking the signals from the EGFR, a protein found in abnormally high levels on the surface of many types of cancer cells, particularly NSCLC cells.
By using QIAGEN’s diagnostic test, doctors will be able to identify patients with the EGFR mutation who might benefit most from treatment with IRESSA, through a blood test.
Currently the main method of evaluating EGFR mutation status includes the collection of tumour tissue by needle biopsy or during resection.
The diagnostic 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.
According to the company, the test has showed robust and reliable identification of EGFR mutation status using samples from the Phase IV IRESSA follow-up measure (IFUM) study.
Both the companies are seeking approval from the European Medicines Agency (EMA) for the ctDNA test, as a companion diagnostic for IRESSA.
AstraZeneca senior vice president of Global Product Strategy for Oncology Mondher Mahjoubi 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.”
QIAGEN CEO Peer Schatz said: “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.”
QIAGEN provides sample and assay technologies that are used to transform biological materials into valuable molecular information.
Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue, while assay technologies are used to make these isolated biomolecules visible and ready for interpretation.