Qiagen announced its collaboration deal with AstraZeneca for the development and commercialization of a companion diagnostic to be mixed with the latter's oral monotherapy anti-cancer treatment.
The project is based on a main framework contract signed by the companies last year and plans to develop and sell a novel liquid diagnostic which evaluates plasma samples and assess the epidermal growth factor receptor (EGFR) mutation status in non-small cell lung cancer (NSCLC) patients.
The assay guides the NSCLC treatment with AstraZeneca's targeted non-small cell lung cancer therapy, IRESSA when tumor tissue is unavailable. Qiagen offers its therascreen EGFR RGQ PCR kit as a companion diagnostic based on tissue for lung patients, approved by the United States' Food and Drug Administration in July last year and China last May.
IRESSA is an EGFR tyrosine kinase inhibitor (TKI) which obstructs the EGFR signals which results to tumor growth. EFGR is a protein in irregularly high levels on the cancer cell surface, specifically NSCLC cells. With the use of Qiagen's diagnostic test, the doctors can identify EGFR mutation in patients and through a blood test, identify those who may benefit from the treatment with IRESSA.
The current method of evaluation EFGR mutation status entails the collection of tumor tissue during resection or through needle biopsy. The patients who were treated with EFGR-TKI whose disease progressed currently have to undergo another biopsy to examine whether or not they have the T790M mutation. CtDNA (circulating DNA) based diagnostic tests offer an alternative way to identify the specific mutation.
"This collaboration will further expand QIAGEN's rapidly growing portfolio of liquid biopsy solutions for personalized healthcare which paves a path for patient monitoring using blood tests for future QIAGEN therascreen companion diagnostics," Qiagen CEO Peer Schatz said. He said that the company is changing its treatment design with very reliable genomic tests that are based on blood samples and other body fluids. This will provide both physicians and patients with more options to identify treatments and check progress.
AstraZeneca believes it could reach $3 billion of AZD9291 sales per year. T790M develops in around 50 percent of lung cancers which are resistant to current EGFR inhibitors such as IRESSA.
