Merck Serono and Sysmex Inostics Announce First Liquid Biopsy RAS Biomarker Testing Center Opens: Important Milestone fo

DARMSTADT, Germany and BARCELONA, Spain, February 20, 2015 /PRNewswire/ --

- Vall d'Hebron, Spain: first hospital to use liquid biopsy RAS biomarker
testing technology
- Leading research center will use technology to evolve understanding of who
will benefit most from targeted treatment to improve patient outcomes
- Liquid biopsy RAS biomarker test is on course to receive its CE mark in coming
months to make it widely accessible for patients

Merck Serono, the biopharmaceutical business of Merck, announced today that the first liquid biopsy RAS biomarker testing center has opened in Vall d'Hebron's Institute of Oncology, Barcelona, Spain, and will initially test patients as part of its research program. This is an important milestone in making the new liquid biopsy RAS test available to patients with metastatic colorectal cancer (mCRC), and a significant step forward in Merck Serono's collaboration with Sysmex Inostics GmbH, Hamburg, Germany. The liquid biopsy method, also known as blood-based biomarker testing, is a simplified and rapid approach for determining the RAS (KRAS and NRAS) mutation status of tumors, as it requires a single blood draw, rather than a tissue biopsy or surgical procedure.[1]

"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 liquid biopsy RAS biomarker test to patients in one of Europe's leading oncology centers," said Belen 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."

The liquid biopsy RAS biomarker test will help to advance precision medicine, and also has the potential to provide mutation status results within days, helping to guide treatment decisions.[1] Approximately half of patients with mCRC present with tumors with RAS mutations.[2] 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(R) (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.[3-9]

The liquid biopsy RAS biomarker test is expected to receive its European Conformity approval (CE mark) in the coming months, making it accessible to a wider population of mCRC patients. The test will then be implemented in numerous medical centers across the world. The Vall d'Hebron Institute of Oncology will be the first test center of its kind, with further laboratories to be established throughout 2015, including in Australia, France, Germany, Italy and the UK, among others.

"This is a significant step in our collaboration with Merck Serono," said Fernando Andreu, CEO of Sysmex Inostics. "We are pleased to have The Vall d'Hebron Institute of Oncology as the first institution to offer our highly sensitive OncoBEAM(TM) 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(TM) assays."

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, Director of the Vall d'Hebron Institute of Oncology. "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 useful tool for treatment decisions. The liquid biopsy method can potentially save time, compared with current tissue-based RAS testing, and spares patients from a tissue biopsy or surgical procedure. We will only need a sample of blood, and we can then potentially provide results in 2-3 days."

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.[10] 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.[10] Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in menthan in women.[10]

About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as Plasma-Sequencing and BEAMing. With BEAMing being one of the most sensitive and quantitative technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics' BEAMing services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive plasma DNA based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, BEAMing tests (OncoBEAM) are available through a CLIA certified laboratory for routine clinical analysis.

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

About Erbitux

Erbitux(R) is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN).

Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.

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