In 2014, the companies entered into an agreement to collaborate on developing the liquid biopsy test and established the first test centre for research use at the Vall d’Hebron Institute of Oncology in Barcelona, Spain.
With the CE mark, the test will now be made available to patients with metastatic colorectal cancer (mCRC) in Europe, Asia and Australia.
Known as OncoBEAM RAS CRC assay, the testing technology can be leveraged to determine which patients would benefit from anti-epidermal growth factor receptor (anti-EGFR) therapies, such as Erbitux.
Merck biopharma business chief marketing and strategy officer Rehan Verjee said: "The CE mark approval of the liquid biopsy RAS biomarker test is therefore a pivotal milestone for patients with metastatic colorectal cancer, as it allows for informed and rapid treatment decisions.
"We, with our partner Sysmex Inostics, can now start making this test available to more patients around the world."
The liquid biopsy RAS biomarker test is a comprehensive 34-mutation panel based on BEAMing (beads, emulsion, amplification and magnetics) technology.
The test can be conducted on a small blood sample of 10ml replacing the requirement of a tissue biopsy, to determine the mutation status of tumors.
It issues a quicker mutation status results which enable physicians to determine the course of treatment quickly.
Vall d’Hebron University Hospital Medical Oncology Department director head Professor Josep Tabernero said: "The speed at which the test results become available has helped us initiate effective treatments faster, which has led to improved patient outcomes."
Image: A view of the Vall d’Hebron University Hospital in Spain. Photo: courtesy of JT Curses.