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Sysmex Inostics and Merck Serono announce first RAS testing center implementing Sysmex Inostics’ blood-based OncoBEAM™ testing in Spain: Important milestone for mCRC patients

2015

 

Sysmex Inostics today announced the first RAS biomarker testing site offering their blood-based OncoBEAM™ tests in Spain.

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced the first RAS biomarker testing site offering their (Sysmex Inostics) blood-based OncoBEAM™ tests in Spain. Aside from Sysmex Inostics’ US-based CLIA certified laboratory, the Vall d’Hebron Institute of Oncology located in Barcelona, Spain, will be the first of numerous medical centers globally to use OncoBEAM™ assays for patients with metastatic colorectal cancers (mCRC) once CE Mark is received. This marks an important milestone in Sysmex Inostics’ collaboration with Merck’s biopharmaceutical business, Merck Serono, for the development and commercialization of a RAS biomarker testing kit for patients with mCRC, which was signed at a ceremony coinciding with the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, U.S in June 2014.

“This is a significant step in our collaboration with Merck Serono”, said Fernando Andreu, CEO of Sysmex Inostics. “We are pleased to have Vall d’Hebron’s Institute of Oncology as the first institution to offer our highly sensitive OncoBEAM™ tests for blood-based diagnostics. This collaborative approach between Merck Serono and Sysmex Inostics along with the reputation and expertise of Vall d’Hebron is another major step in advancing personalized medicine for metastatic colorectal cancer patients and enhancing the value of our clinical OncoBEAM™ assays”.

The blood-based RAS biomarker test will help to advance precision medicine, and also has the potential to provide mutation status results within days which, in turn, can help guide treatment decisions.1 In addition, such testing may become the method of choice where a tissue specimen is difficult to obtain – for example in patients whose physical condition does not allow for a surgical procedure. Approximately half of patients with mCRC present with tumors with RAS mutations. Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody therapies, such as Erbitux® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.3-9

“We are excited that within less than one year of announcing our collaboration with Sysmex Inostics we are already making significant progress in bringing this new blood-based RAS biomarker test to patients in one of Europe’s leading oncology centers,” said Belén Garijo, Member of the Executive Board of Merck and CEO Healthcare, at the opening event in Barcelona. “Merck Serono is committed to improving patient outcomes and supporting clinicians in advancing the standard of care in metastatic colorectal cancer, and we are delighted that we will soon be able to offer a new method of RAS biomarker testing to the international oncology community.”

Vall d’Hebron’s Institute of Oncology will use blood samples from mCRC patients to advance research into RAS biomarkers. The ability to test for these mutations at Vall d’Hebron with a potentially quicker and easier testing method could improve the standard of care for patients.

“As patients with metastatic colorectal cancer (mCRC) can respond differently to various treatments, it is important to understand more about the tumor, especially its biology and genetics,” said Professor Josep Tabernero, Head of the Medical Oncology Department of Vall d’Hebron University Hospital. “Once this liquid biopsy RAS biomarker test has received its CE mark it will become an important advance in testing mCRC patients and be a usefultool for treatment decisions. The liquid biopsy method can potentially save time, compared with current tissue-based RAS testing, and spares patients of a tissue biopsy or surgical procedure. We will only need a sample of blood, and we can then potentially provide resultsin 2-3 days”.

Sysmex Inostics highly sensitive RAS OncoBEAM™ tests allow for molecular genetic analysis of cell-free tumor DNA from blood or plasma, delivering an individualized approach to complement treatment decision-making in oncology.

References

  1. Diaz LA Jr and Bardelli A. J Clin Oncol 2014;32(6):579−86.
  2. Vaughn CP, et al. Genes Chromosomes Cancer 2011;50(5):307−12.
  3. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.
  4. Schwartzberg LS, et al. J Clin Oncol 2014;32(21):2240-7.
  5. Bokemeyer C, et al. Oral presentation at the 2014 American Society of ClinicalOncology Annual Meeting, May 30-June 3, 2014. Abstract No:3505.
  6. Stintzing S, et al. Oral presentation at the 2014 European Society of MedicalOncology Annual Meeting, September 26-30, 2014. Abstract No:LBA11.
  7. Van Cutsem E, et al. J Clin Oncol 2015;pii: JCO.2014.59.4812.
  8. Erbitux® (cetuximab) SmPC, 2014. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000558/WC500029119.pdf. Last accessed February2015.
  9. Vectibix® (panitumumab) SmPC, 2014. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000741/WC500047710.pdf. Last accessed February2015.

About Merck Serono

Merck Serono is the biopharmaceutical business of Merck. With headquarters in Darmstadt,Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology. For more information, please visit www.merckserono.com.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials – and generated total revenues of € 11.1 billion in 2013. Around 39,000 Merck employees workin 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany, holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.

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 BEAMing and Plasma Sequencing. Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. With BEAMing being one of the most sensitive technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics’ OncoBEAM™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 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.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 indiagnostic 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 6,000 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 www.sysmex.co.jp/en/.

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