Blood-based RAS Biomarker Test Now Available in Slovakia

News provided by

Sysmex Inostics GmbH

15 Mar, 2016, 14:00 GMT

MARTIN, Slovakia, March 15, 2016 /PRNewswire/ --

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced its first RAS biomarker testing site in Slovakia opening at Martinské bioptické centrum, spol. s.r.o. (Martin´s Biopsy Center. Ltd.). The center will offer the Sysmex Inostics blood-based OncoBEAM® test which is a non-invasive, fast method to determine the RAS status crucial for therapy planning of RAS wild type mCRC patients[1].

The highly sensitive OncoBEAM® RAS CRC test, developed by Sysmex Inostics GmbH in collaboration with Merck, 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[2].

"The OncoBEAM® test result can be available within only a few days, supporting treatment decisions immediately," says Prof. Lukás Plank, director of the new center. "This is valuable time that we gain for therapy planning."

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[3]-[6]. The certification of conformity with the European harmonized directives (CE-labelling) is expected this month, allowing routine use of the test for patient diagnosis.

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

References 

  1. Van Cutsem et al., 2015 J Clin Oncol 33.692-700
  2. Diaz LA Jr and Bardelli A. J Clin Oncol 2014;32(6):579−86.
  3. Sorich et al. 2015 Annals Oncol 26.13-21
  4. NCCN guidelines colon cancer 3.2015
  5. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9
  6. http://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. 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 http://www.sysmex-inostics.com or email info@sysmex-inostics.com.