Merck receives CE Mark for liquid biopsy biomarker for patients with colorectal cancer

11th April 2016 (Last Updated April 11th, 2016 18:30)

Science and technology company Merck has received CE Mark approval for a new RAS biomarker-based liquid biopsies, called OncoBEAM, which has been co-developed and marketed by Sysmex Inostics.

Science and technology company Merck has received CE Mark approval for a new RAS biomarker-based liquid biopsies, called OncoBEAM, which has been co-developed and marketed by Sysmex Inostics.

After receiving approval, Merck can now provide blood-based test to patients with metastatic colorectal cancer (mCRC) in Europe, Asia, Latin America and Australia.

Recent data has demonstrated that the fundamental technology of the RAS assay OncoBEAM for CRC has been proved to have similar performances to conventional testing of tissue biopsies.

The data also showed that the OncoBEAM RAS CRC test can be used to identify those patients to benefit from anti epidermal growth factor receptor (EGFR) therapies, such as Erbitux.

"The speed the test results become available has helped us initiate effective treatments faster, which has led to improved patient outcomes."

Merck biopharmaceutical business chief marketing and strategy officer Rehan Verjee said: "In line with our philosophy to provide the patient at the center of our activities, we strive to consider all aspects of the disease and therapeutic response of the patients.

"We want to focus on projects that both the experience of patients with treatment improve as well as their results.

"The granting of the CE Marking for the liquid biopsy RAS biomarker is therefore an important milestone for patients with metastatic colorectal cancer because it allows rapid treatment decisions. Now we can start together with our partner Sysmex Inostics, the test more patients worldwide available to put."

The liquid biopsy RAS biomarker includes a group of 34 mutations based on the beaming that involves beads, emulsion, amplification and magnetics technology.

The test requires just a small blood sample of 10ml instead of a tissue sample to verify the mutation status of a tumour and can deliver results of the mutation status within days, helping quicker treatment decisions.

Spain's Vall d'Hebron University Hospital medical oncology department director head Josep Tabernero said: "As the first test centre to use the liquid biopsy RAS biomarker testing technology, we have seen firsthand how this technology has advanced treatment decision-making.

"The speed at which the test results become available has helped us initiate effective treatments faster, which has led to improved patient outcomes."

In 2014, Merck and Sysmex Inostics completed a cooperation agreement for the joint development and marketing of liquid biopsy tests and last February, they opened the first test centre for research purposes at the Department of Oncology in the Hospital Vall d' Hebron in Barcelona, Spain.