Tuesday, March 17, 2015

QIAGEN is rapidly expanding with new technology for the analysis of circulating tumor cells … – PR Newswire (press release)

German, Maryland and Hilden, Germany (ots / PRNewswire)

 - From AdnaGen acquired technology enables innovative, non-invasive blood tests for the analysis of circulating tumor cells for use in personalized medicine - QIAGEN and Tokai Pharmaceuticals cooperate in the development and marketing of the first authorized accompanying tests based on circulating tumor cells for the control of therapies for prostate cancer - QIAGEN expanded portfolio of liquid biopsy solutions includes all major technologies: cell-free DNA, exosomes, as well as circulating tumor cells 

QIAGEN NV today announced a major expansion of its industry-leading portfolio of liquid biopsies through the acquisition of an innovative technology which allows the accumulation and analysis of circulating tumor cells (Circulating Tumor Cells, CTCs) from blood samples.

At the same QIAGEN announced a new partnership with Tokai Pharmaceuticals, Inc., under which the new CTC technology to develop a therapy-accompanying tests for Tokai’s new drug Galeterone to be used. This innovative compound is in the final stages of clinical development for the treatment of castration-resistant prostate cancer (CRPC). The non-invasive test is to determine the expression of the biomarker AR-V7, which has been found in recent studies as a useful indicator for the control of therapies for CRPC patients. The therapy accompanying test will be marketed jointly by both partners. Financial details of the agreement were not disclosed.

“As a pioneer in the field of non-invasive liquid biopsies we look forward to further expanding our industry-leading pipeline. Developed by AdnaGen innovative method for the detection of CTCs is already used by leading experts at Johns Hopkins University used in Baltimore as part of novel diagnostic method and represents an important extension of our leading liquid biopsy portfolio for molecular diagnostics. The partnership with Tokai Pharmaceuticals as one of the collaborations that we maintain in this area with pharmaceutical companies, aims to develop a therapy-accompanying tests from on the basis of CTCs from liquid biopsies and has the potential to improve treatment outcomes in prostate cancer, “said Peer M. Schatz, CEO of QIAGEN. “After the success of the first accompanying tests on molecular biomarkers in Flüssigbiospien, who has been accepted to control the treatment of solid tumors in Europe, we are expanding our portfolio of high-precision tests for analyzing non-invasively obtained samples of body fluids that are lighter than traditional tissue biopsies are accessible. Our portfolio of solutions for liquid biopsies has the potential to generate valuable insights for treatment and to improve the outlook for patients. ”

Circulating tumor cells play a key role in the understanding of cancer and the development of metastases. The test material they offer great potential for the control of therapies, assessing the burden of disease and monitoring of tumor growth. Since CTCs occur only in small amounts in the blood, makes its enrichment and characterization nevertheless a major technological challenge. The proprietary AdnaGen technology provides a complete solution for the detection and analysis of CTCs in clinical applications. It accumulates tumor cells using magnetic particles in an antibody mixture in (a process which is referred to as immunomagnetic cell enrichment), isolated messenger RNA (messenger RNA, mRNA) and prepares them subsequently using the reverse transcriptase polymerase chain reaction (RT-PCR) to Analysis on. An essential part of the portfolio of AdnaGen has already been developed for use with QIAGEN’s automated solutions and supplies and markets.

QIAGEN’s leading portfolio of solutions for pre-analytical processing of molecular biomarkers from blood or other body fluids covers a wide breadth of applications in the field of liquid biopsies from:

 - Cell-free circulating nucleic acids (cfDNA), which are emitted mainly of dead cells into the blood or in other body fluids. This phenomenon occurs for each person, but go to certain constellations of physiological conditions and symptoms associated with a significantly higher concentration of cfDNA associated, for example, in pregnant women or patients with cancer or autoimmune diseases. - In the smallest vesicles (exosomes) circulating nucleic acids and proteins: These microvesicles secreted by cells are part of the communication system of the body. Each exosome can transport a minute charge of genetic instructions in the form of DNA or RNA molecules from blood, urine or other body fluids. Since exosomes transfer this genetic messages from cell to cell, they are often referred to as "the Twitter cells". - Circulating tumor cells (CTCs) are discharged from the primary tumor into the blood and play an important role in the development of metastases  in other areas of the body. 

The partnership with Tokai Pharmaceuticals will bring the CTC-based liquid biopsy technology for therapy-accompanying tests for the application. It aims at the development of the first authorized accompanying tests on CTC basis, to be used to control drug therapies with Tokai in castration-resistant prostate cancer Galeterone (CRPC). This oral small-molecule drug is currently being evaluated by the FDA under an accelerated approval process ("Fast Track Designation") and to 2015 occur in the second half along with QIAGEN's being developed AR-V7 test in clinical phase III trials. The companion diagnostic test QIAGEN will measure the RNA expression in CTCs to detect the biomarker AR-V7 (androgen receptor splice variant 7), which was identified as an indicator of poor response to certain oral therapies for the treatment of castration-resistant prostate cancer. The test is run on QIAGEN's detection platform Rotor-Gene Q MDx, part of the QIAsymphonySP family.

"We are delighted to expand our partnership with QIAGEN to the development of the AR-V7 accompanying tests for use in the forthcoming 148-patient Phase III study ARMOR3-SV our lead product Galeterone. We are convinced that the availability of non-invasive AR-V7-accompanying tests will be in the future prostate cancer patients and physicians the ability to make informed treatment decisions, "said Jodie Morrison, President and Chief Executive Officer of Tokai Pharmaceuticals. "QIAGEN's experience in the global commercialization of approved companion diagnostics addresses an important part of our strategy for global marketing of Galeterone for CRPC patients."

Prostate cancer is the second most commonly diagnosed cancer in men. The World Health Organization (WHO), 2012 were originally diagnosed worldwide 1.1 million cases of this disease and 300,000 deaths recorded. In Europe concerned prostate cancer in 2012 about 400,000 men and led to 92,000 deaths. The American Cancer Society is based for the year 2015 of 220,000 new cases of prostate cancer and 27,000 deaths - this would Prostate cancer is the second most common cause of cancer death in American men.

The CTC test for Tokai is being developed by QIAGEN Manchester, the global center for the development and approval of molecular diagnostic tests available from QIAGEN.

QIAGEN has the CTC technology and other assets of the AdnaGen GmbH, a subsidiary of Alere Inc. acquired. These include the CE-IVD certified products AdnaTest Breast Cancer and Prostate Cancer AdnaTest, enable improved monitoring of therapy and earlier detection of recurrence in cancer. Both are already marketed in Europe.

Leading the way in liquid biopsies and in personalized medicine

QIAGEN is a leader in the field of liquid-based tests and biopsies in isolation and enrichment technologies for molecular biomarkers in blood and other body fluids. Liquid biopsies have enormous potential in the diagnosis and monitoring of many diseases - particularly cancer - to enhance and complement invasive, time-consuming tissue biopsies. In January 2015, QIAGEN brought the therascreen EGFR RGQ plasma-PCR kit on the market. It is a companion diagnostic test in conjunction with a leading therapy for non-small cell lung cancer, if no tumor tissue samples are available. The kit has received a CE-IVD marking for use in over 30 European countries and is the first approved companion diagnostic test for solid tumors based on liquid biopsies.

QIAGEN is a global leader in testing for personalized medicine based on tissue biopsies and liquid. Under personalized medicine refers to the strategy, accompanying tests as a basis for the use of drugs in the treatment of cancer and other diseases to use. The company offers a variety of markets to tests that cover a variety of molecular biomarkers and can be performed on PCR, and sequencing multimodal next-generation platforms. The growing pipeline of QIAGEN includes over 20 collaborative projects with pharmaceutical and biotechnology companies for the commercialization of companion diagnostics.


QIAGEN NV, a Netherlands holding company, is the leading global provider of complete solutions for recovering valuable insights from molecular biological samples. The samples from QIAGEN technologies enable the purification and processing of DNA, RNA and proteins from blood, tissues and other substances. Test technologies make these biomolecules visible and ready for analysis. Bioinformatics solutions and knowledge databases help in the interpretation of data to obtain relevant and practically useful insights. Automation solutions integrate them into seamless and cost-effective molecular testing workflow. QIAGEN provides these workflows world more than 500,000 customers in the fields of molecular diagnostics (healthcare), Applied Testing (forensics, veterinary diagnostics and food safety), Pharma (pharmaceutical and biotechnology companies) and research (Life Sciences) are available. 31 December 2014 QIAGEN employs 4,300 people worldwide in over 35 locations. Further information about QIAGEN can be found at http://www.qiagen.com.

Some of the statements in this press release may within the meaning of Section 27A of the Securities Act (US Corporation Act) of 1933, as amended, and Section 21E of the Securities Exchange Act (US Stock Trading Act) of 1934, as supplemented version are forward-looking statements ("forward-looking statements"). The extent that any forward-looking statements relating to QIAGEN's products, markets, strategy and operating results will be made, including, but not limited to the operating results, new product development, new product launches, regulatory filings and financial planning to be expected, this is done based on current expectations and assumptions which are subject to uncertainties and risks. These include: risks associated with management of growth and international operations (including the effects of currency fluctuations and the function of regulatory and logistics processes), variability of operating results and allocations between business segments, the development of markets for our products (including applied testing, personalized medicine, clinical research, proteomics, women's health / HPV testing and molecular diagnostics), changing relationships with customers, suppliers and strategic partners, the competitive environment, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products (including general economic conditions the level and timing of the budget of our clients and other factors), our ability to obtain regulatory approval for our products, difficulties in adapting QIAGEN's products to integrated solutions and producing such products, the Company's ability to develop new product ideas, implement and to protect themselves from their competitors' products stand out and above the competition, market acceptance of new products, the completion of acquisitions and the integration of acquired businesses and technologies. More information can be found in reports that QIAGEN with the US Securities and Exchange Commission (US Securities and Exchange Commission) has filed.


 Public Relations: Dr. Thomas Theuringer Director Public Relations + 49-2103-29-11826 Email: pr@qiagen.com http: // www.twitter.com/qiagen https://www.facebook.com/QIAGEN http://pr.qiagen.com Investor Relations: John Gilardi Vice President of Corporate Communications and Investor Relations + 49-2103-29-11711 Email: ir @ qiagen.com http://ir.qiagen.com 

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