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Blood-based RAS biomarker test now available in Germany

2015

 

Targeted therapy for metastatic colorectal carcinoma (mCRC) is possible through identification of the RAS mutation status.

Targeted therapy for metastatic colorectal carcinoma (mCRC) is possible through identification of the RAS mutation status. Using the OncoBEAM® 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 OncoBEAM® 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 success1.

The OncoBEAM® 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 antibody. 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.

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

References

  1. Diaz and Bardelli 2014 J Clin Oncol 32.579−86
  2. Sorich et al. 2015 Annals Oncol 26.13-21
  3. NCCN guidelines colon cancer 3.2015
  4. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9
  5. www.ema.europa.eu/ema
  6. Van Cutsem 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 OncoBEAM® 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, OncoBEAM® 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 OncoBEAM® blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

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