New Liquid Biopsy RAS Testing for Metastatic Colorectal Cancer Patients now Available for Clinical Practices

Sysmex Inostics, a subsidiary of Sysmex Corporation, announced that its OncoBEAM® RAS CRC test has been granted CE Mark approval. The test, developed by Sysmex Inostics GmbH in collaboration with Merck, can now be accessed by patients with metastatic colorectal cancer (mCRC) across Europe. The OncoBEAM® RAS CRC assay has been shown to have similar performance to conventional tissue-based testing1-3 and can be used to determine which patients would benefit from anti-EGFR therapies, such as Erbitux, as demonstrated by recent data.4-8 "We have achieved a significant milestone with the CE Mark of the OncoBEAM^®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." "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." 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 test has the potential to provide mutation status results within days, which can help guide quicker treatment decisions. Moreover, 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.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." 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 treatment.^10-13 Now with the CE Mark, it is expected to be widely implemented across Europe, Asia, Latin America, and Australia by the end of 2016. OncoBEAM^® is a registered trademark of Sysmex Corporation. OncoBEAM^® is distributed and marketed by Sysmex Inostics, Hamburg, Germany.

About mCRC

Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.¹⁴ 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^®(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.¹⁵ 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.¹⁵ 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.¹⁵

About CE Marking

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.

References

1. Hahn S, et al. Eur J Cancer 2015;51(suppl 3):S79.
2. Jones F, 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. Sorich et al. 2015 Annals Oncol 26.13-21
11. NCCN guidelines colon cancer 3.2015
12. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9
13. www.ema.europa.eu/ema
14. Vaughn CP, et al. Genes Chromosomes Cancer 2011;50(5):307−12.
15. 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: globocan.iarc.fr. Accessed April 2016.

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 €12.8 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.

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. 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.

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 www.sysmex.co.jp/en/. Original press release: http://www.sysmex-inostics.com/news-and-events/press-releases/new-liquid-biopsy-ras-testing-for-metastatic-colorectal-cancer-patients-now-available-for-clinical-practices-546.html