Sysmex Inostics blood-based RAS biomarker test now available in Italy

Date: 2016-07-05 Tags: News, Press release

Naples, 05.07.2016 - Assessing RAS mutation status in patients with mCRC has shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies can improve outcomes in patients with RAS wild-type mCRC. 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. This should reduce the clinical turn around time for Oncologists allowing them to make informed therapy decisions in a timely manner and reducing the complications for patients currently undergoing tissue biopsies. The first center of excellence that implemented the OncoBEAM® RAS test in Italy is the Centro di Ricerche Oncologiche di Mercogliano (CROM) in Naples.

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 success. 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 Cetuximab, as demonstrated by recent data.4-8

"In mCRC, RAS is known to be a key biomarker to predict how well mCRC patients may respond to particular treatments, making it important to know their RAS status as early as possible. The OncoBEAM® CRC RAS test can save time, compared with current tissue-based RAS testing. The liquid biopsy test can also be used as an alternative if tissue for testing is not available." says Prof. Nicola Normanno, director of the Pharmacogenomics laboratory at CROM.

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 treatment9-13. The certification of conformity with the European harmonized directives (CE-labelling) has been granted in April 2016 allowing its use in routine for patient diagnosis.

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

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. Sorich et al. 2015 Annals Oncol 26.13-21
  10. NCCN Clinical Practice Guidelines in Oncology™: Colon Cancer. 
  11. National Comprehensive Cancer Network. V2, 2016. 
  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

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 and Sysmex Inostics' Service Laboratory are located in Hamburg, Germany; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM® blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

Product

ONCOBEAM™ RAS CRC KIT IVD


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