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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

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Sysmex Inostics, a subsidiary of Sysmex Corporation, recently 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.

Source: Sysmex Inostics