QIAGEN announces first-ever regulatory registration of a lung cancer companion diagnostic based on liquid biopsies
Jan 12 2015

QIAGEN announces first-ever regulatory registration of a lung cancer companion diagnostic based on liquid biopsies

  • QIAGEN’s circulating tumor DNA test is now CE-IVD marked to assess EGFR mutation status in non-small cell lung cancer (NSCLC) patients based on plasma samples
  • therascreen EGFR RGQ Plasma PCR kit helps physicians to identify patients who could benefit from treatment with IRESSA when tumor tissue sample is not evaluable
  • QIAGEN pioneering the use of liquid biopsy-based companion diagnostics as a less-invasive option to complement surgical biopsies for genomic profiling of cancers

Hilden, Germany, January 12, 2015 – 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.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample & 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. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of September 30, 2014, QIAGEN employed approximately 4,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

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