Merck and Sysmex Inostics Receive CE Mark Approval for Liquid Biopsy test for Colorectal Cancer Patients

          - The test will help guide physicians to select the most effective treatment for mCRC patients in a timely manner

          Merck, a leading science and technology company, today announced that a new liquid biopsy RAS biomarker test, which they are co-developing and commercializing with Sysmex Inostics, has been granted CE Mark approval. This test will now be made widely accessible for patients with metastatic colorectal cancer (mCRC) in Europe, Asia and Australia. The testing technology, OncoBEAM(R) RAS CRC assay, has been shown to have a similar performance to that of conventional tissue-based testing[1-3] and can be used to determine which patients would benefit from anti-epidermal growth factor receptor (anti-EGFR) therapies, such as Erbitux(R) (cetuximab), as demonstrated by recent data.[4]-[8]

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          "In keeping with our philosophy of patient focus, we strive to evaluate all aspects of the patient journey, to focus our efforts on projects that improve treatment experience and outcomes for the patients," said Rehan Verjee, Chief Marketing and Strategy Officer of Merck's biopharma business. "The CE mark approval of the liquid biopsy RAS biomarker test is therefore a pivotal milestone for patients with metastatic colorectal cancer, as it allows for informed and rapid treatment decisions. We, with our partner Sysmex Inostics, can now start making this test available to more patients around the world."

          "We have achieved a significant milestone with the CE Mark of the OncoBEAM(R) RAS colorectal cancer assay," said Fernando Andreu, CEO of Sysmex Inostics. "Together with Merck, we are advancing biomarker testing in metastatic colorectal cancer, and we are already seeing strong acceptance and uptake of the test in pilot centers, with clinicians globally recognizing the clinical value of a blood-based test."

          The liquid biopsy RAS biomarker test is a comprehensive 34-mutation panel that is based on the BEAMing (Beads, Emulsion, Amplification and Magnetics) technology. The test only requires a small blood sample (10 ml), rather than a tissue biopsy, to determine the mutation status of tumors.[9] The test has the potential to provide mutation status results within days, which can help guide quicker treatment decisions.[9]

          "As the first test center to use the liquid biopsy RAS biomarker testing technology we have seen firsthand how this technology has advanced treatment decision-making," said Professor Josep Tabernero, Director Head of the Medical Oncology Department of Vall d'Hebron University Hospital, Spain. "The speed at which the test results become available has helped us initiate effective treatments faster, which has led to improved patient outcomes."

          Merck and Sysmex Inostics entered into an agreement to co-develop and commercialize the liquid biopsy test on May 19, 2014 and opened the first test center, for research use only, at the Vall d'Hebron Institute of Oncology in Barcelona, Spain on February 20, 2015. Now with the CE Mark, the liquid biopsy RAS biomarker testing technology is expected to be widely implemented across Europe, Asia, Latin America and Australia by the end of 2016.

          References

          1) Hahn S, et al. Eur J Cancer 2015;51(suppl 3):S79.
          2) Jones S, et al. Poster discussion presentation at the European Cancer Congress 2015, September 25-29, 2015.
          3) Scott R, et al. Ann Oncol 2015;16(suppl 4):iv1-iv100.
          4) Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.
          5) Schwartzberg LS, et al. J Clin Oncol 2014;32(21):2240-7.
          6) Bokemeyer C, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3505.
          7) Stintzing S, et al. Oral presentation at the European Society for Medical Oncology Congress, September 26-30 2014. Abstract No:LBA11.
          8) Ciardiello F, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3506.
          9) Diaz LA and Bardelli A. J Clin Oncol 2014;32(6):579−86.
          10) Vaughn CP, et al. Genes Chromosomes Cancer 2011;50(5):307−12.
          11) Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available at: http://globocan.iarc.fr. Accessed April 2016.

          About mCRC

          Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.[10] Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux(R) (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.[4-8] Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.[11] An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.[11] Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.[11]

          About CE Mark

          CE Mark is a mandatory conformity marking for certain products sold within the European Economic Area, and is a declaration that the product meets the essential requirements of the applicable EC directives.

          About Sysmex Inostics

          Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as Plasma-Sequencing and BEAMing. With BEAMing being one of the most sensitive and quantitative technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics' BEAMing services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive plasma DNA based IVD tests supported by a growing network of partners to cover the entire IVD development process.

          Sysmex Inostics' headquarters are located in Hamburg, Germany and Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM blood testing and the BEAMing technology refer to http://www.sysmex-inostics.com [https://mail.respublica.ca/owa/redir.aspx?C=oSig0Nx4N0mm1S66SQvgq35ibLRUQ9MIJp3LulV5OEviI5S0v0ZEa8R2QvMN3vubre1H8wLPZHQ.&URL=http%3a%2f%2fwww.sysmex-inostics.com ] or email [email protected].

          About Erbitux

          Erbitux(R) is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

          The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

          Erbitux has already obtained market authorization in over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN).

          Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.

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          About Merck

          Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 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 2015, Merck generated sales of EUR12.8 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, MilliporeSigma and EMD Performance Materials.