QIAGEN's circulating tumor DNA test CE-IVD marked to assess genomic mutation NSCLC patients

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) announced today the CE-IVD marking of its novel liquid biopsy-based companion diagnostic that analyzes circulating nucleic acids obtained from blood samples to assess an important genomic mutation in patients with non-small cell lung cancer (NSCLC), the most common form of this cancer.

The registration, which applies to more than 30 European countries, makes the new therascreen EGFR RGQ Plasma PCR kit the first-ever regulated companion diagnostic assay that has demonstrated clinical utility for guiding treatment decisions in patients with solid tumors based on the analysis of molecular biomarkers obtained from a body fluid (liquid biopsy).

The launch of this kit, which is planned for January 2015, comes as the European Medicines Agency (EMA) extended the drug label of IRESSA® to include the detection of EGFR mutations in circulating tumor DNA (ctDNA) obtained from a blood (plasma) sample when a tumor sample is not evaluable. This change was based on the IFUM (IRESSA Follow-Up Measure) study, which assessed the mutation status in tumor and circulating tumor DNA (ctDNA) samples derived from plasma using QIAGEN kits.

The therascreen EGFR RGQ Plasma PCR kit, co-developed by QIAGEN and AstraZeneca (LSE, NYSE and OMX: AZN), helps physicians to identify those advanced NSCLC patients who could benefit from treatment with IRESSA when a suitable tumor sample is not available. This test uses QIAGEN's QIAamp Circulating Nucleic Acid Kit for DNA purification, analysis is based on an adapted version of QIAGEN's therascreen® EGFR RGQ PCR kit (therascreen EGFR test), which has already been validated and commercialized for use with FFPE (Formalin-Fixed, Paraffin-Embedded) solid tumor samples. The test is performed on QIAGEN's Rotor-Gene Q PCR detection platform, a member of the QIAsymphony family of automated instruments. QIAGEN also recently filed a U.S. regulatory submission for a tissue-based EGFR test using an FFPE sample as a proposed companion diagnostic to guide treatment with IRESSA.

"Our collaboration with AstraZeneca has achieved an important milestone with the European regulatory registration of this new technology to help in guiding the treatment of lung cancer patients," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "Through this collaboration and other partnerships, QIAGEN is building an extensive portfolio of liquid biopsy solutions for personalized healthcare, creating highly reliable genomic tests and automated workflows based on samples of blood or other body fluids to help make treatment decisions and monitor treatment response and disease progress."

Ruth March, VP Personalised Healthcare and Biomarkers at AstraZeneca, said: "We use companion diagnostics to target medicines such as IRESSA to patients most likely to benefit. This innovative test, developed in partnership between AstraZeneca and Qiagen, is the first to receive regulatory approval to assess EGFR mutation status from blood samples. Testing circulating tumour DNA gives physicians the option to prescribe IRESSA to patients when solid tumour tissue is unavailable and a surgical biopsy is impractical. This technology has the potential to transform treatment for these cancer patients."

IRESSA (gefitinib), the oral monotherapy anti-cancer treatment from AstraZeneca PLC, is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor that acts to block signals for cancer cell growth and survival. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, particularly in non-small cell lung cancer. Certain EGFR gene mutations occur in a significant number of lung cancers, and these mutation-positive tumors are particularly sensitive to IRESSA - so diagnostic testing to determine a patient's mutation status (positive or negative) is important in making treatment decisions. IRESSA was approved in Europe in 2009 for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK.

QIAGEN is at the forefront in developing and validating companion diagnostics to guide the selection of medicines in treating cancer and other diseases, spanning a range of automation platforms and sample types. The company already offers the therascreen EGFR test as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014, and has developed an industry-leading portfolio of liquid biopsy technologies. This product offering includes the QIAamp Circulating Nucleic Acid Kit, which is considered the gold standard sample technology for the processing of free circulating DNA, the REPLI-g product line, which enables genomic analysis from single cells, and the recently launched exoRNeasy kits to isolate exosomal RNA from serum/plasma, even tiny samples. In addition, QIAGEN is developing a pipeline of liquid biopsy-based tests for research and eventual use in clinical diagnostics.