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Blood-based IVD RAS biomarker test now available in France

2016

 

RAS biomarker testing site opening at the Biopathology department of the ICL, Nancy

Nancy, France – Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced its first RAS biomarker testing site in France opening at the Biopathology department of the Institut de Cancérologie de Lorraine (ICL), Nancy. The center will offer Sysmex Inostics blood-based OncoBEAM® IVD test, developed by Sysmex Inostics GmbH in collaboration with Merck, which is a non-invasive, fast method to determine the RAS status crucial for therapy planning of RAS wild type mCRC patients.

“With the blood-based mutation test we aim at a dramatic reduction of the delay for mutation analysis and therefore accelerated optimized initiation of personalized therapy “, says Prof. Jean-Louis Merlin, head of the Tumor biology Unit of the new center.

Determining RAS mutations in circulating cell-free DNA with the OncoBEAM® RAS CRC test is highly sensitive, and only requires a single blood-draw. Thus, the blood-based test, also called liquid biopsy, represent an alternative to tumor tissue-based test that requires biopsies or other surgical specimen. This test can also be performed when no tumor tissue is available or when reducing the delay for providing the 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 Erbitux, as demonstrated by recent data.4-8

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 treatment9-12. 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.

As of April 2016, and under the acronym “ColoBEAM”, the ICL is conducting a multicenter prospective study comparing the implementation in real-life clinical practice of OncoBEAM® RAS CRC test on blood to standard test on formalin fixed and paraffin embedded tumor tissue.

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 guidelines colon cancer 3.2015
  11. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9
  12. 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 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.

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