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Dec. 04, 2015

Blood-based RAS biomarker test now available in Germany

  Sysmex Corporation (HQ: Kobe Japan: Chairman and CEO: Hisashi Ietsugu) subsidiary Sysmex Inostics has developed the OncoBEAMTM RAS CRC Test for blood-based RAS genetic mutations in metastatic colorectal cancer in cooperation with Merck. The 1st center offering the new test procedure has now opened in Germany.

  Targeted therapy for metastatic colorectal carcinoma (mCRC) is possible through identification of the RAS mutation status. Using the OncoBEAMTM RAS CRC test, developed by Sysmex Inostics GmbH in collaboration with Merck, the RAS mutation status can now also be determined using the blood: a rapid and simple method allowing even more patients to have access to personalized mCRC therapy.

Optimization of therapy planning - a single blood-draw is sufficient
  The first center of excellence for RAS biomarker testing in Germany offering the new test procedure was opened at Universitätsklinikum Knappschaftskrankenhaus Bochum during a joint press conference involving both companies and the Ruhr University Bochum. "With the blood-based mutation test we receive the results within only a few days - this is precious time that we gain for planning the therapy", says Prof. Wolff Schmiegel, director of the new center. The highly sensitive OncoBEAMTM RAS CRC test is a simplified method for determining the RAS mutation status of tumors, which requires only a single blood-draw. Thus, the blood-based test is an alternative to tissue biopsies or other surgical procedures, and can also be performed when no tumor tissue is available or a rapid test result is crucial for therapy success.1
 
  The OncoBEAMTM RAS assay is a comprehensive test which includes 34 KRAS and NRAS mutations reflecting the recommendations of the NCCN, ESMO as well as EMA guidelines to determine the RAS mutation status before initiating treatment2-5. The certification of conformity with the European harmonized directives (CE-labelling) is expected in the coming months, which will allow using the test in routine for patient diagnosis.

Targeted: Relevance of biomarkers for therapy success
  Predictive biomarkers are important in oncology for the effectiveness and individual response to the therapy. With RAS mutation analysis, a mCRC targeted therapy is possible: Studies show that patients with KRAS and NRAS wild type tumors can benefit from a therapy with the EGFR antibodies. Therefore, identification of the RAS mutation status is crucial for therapy planning of RAS wild type mCRC patients6.

Personalized medicine: Driving progress forward through collaboration
  "Merck is researching biomarkers and appropriate further diagnostics in order to allow cancer patients access to personalized therapies. The collaboration with Sysmex Inostics has enabled us to make significant progress in this", emphasizes Dr. Bettina Bauer, Director of the Business Unit Oncology, Merck Serono GmbH. "With the new CRC blood test our common goal is to provide physicians with crucial information for selecting the therapy, and to give the patient considerably value", states Dr. Michael Schaefer, Managing Director of Sysmex Inostics GmbH. “Sysmex Inostics is committed to driving precision medicine and we will continue to expand our liquid biopsy product pipeline to improve the standard of care for patients”. Both companies are collaborating with various partners in industry and research institutes to continue pushing forward with personalized medicine in the area of oncology.

  OncoBEAMTM is a registered trademark of Sysmex Corporation. OncoBEAMTM is distributed and marketed by Sysmex Inostics, Hamburg, Germany.

References
  1. Diaz LA Jr and Bardelli A. J Clin Oncol 2014;32(6):579−86.
  2. Sorich et al. Extended RAS mutations and anti-EGFR antibody survival benefit in metastatic colorectal cancer.
      Annals of Oncology 26: 13–21, 2015.
  3. NCCN guidelines colon cancer 3.2015
  4. Van Cutsem et al. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals of Oncology 25
      (Supplement 3): iii1–iii9, 2014.
  5. http://www.ema.europa.eu/ema
  6. Van Cutsem E et al., 2015 J Clin Oncol 33.692-700

About Merck
  Merck is a leading science and technology company in healthcare, life science and performance materials. Around 40,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2014, Merck generated sales of €11.3 billion in 66 countries.
  Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.
  Further information can be found at www.merckserono.de or www.merckgroup.com.

About Sysmex Inostics
  Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection in blood through highly sensitive molecular methods. Our OncoBEAMTM blood-based tests deliver a minimally invasive alternative for sensitive real time molecular diagnostics to improve cancer characterization and treatment.
  Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, OncoBEAMTM tests are available through a CLIA certified laboratory for routine clinical analysis. 
  Sysmex Inostics’ headquarters are located in Mundelein, IL; Sysmex Inostics’ Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics’ Service Laboratory is located in Hamburg, Germany. For more information on OncoBEAMTM blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

About Sysmex Corporation
 Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 40 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R & D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, China and Asia Pacific and employs more than 7,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange. For more information about Sysmex Corporation and its affiliate companies, please visit http://www.sysmex.co.jp/en/.
 

 

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