QIAGEN (NASDAQ: QGEN) 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 (NYSE: 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."