Merck receives CE Mark approval for new liquid biopsy test for colorectal cancer

pharmafile | April 6, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing |  CE Mark, Merck, biomarker, biopsy, colorectal cancer, liquid biopsy, ras, sysmex inostics 

Merck (ETR: MRK) has announced that their new liquid biopsy RAS biomarker test for metastatic colorectal cancer, developed in collaboration with Sysmex Inostics, has been granted CE Mark approval. The test will now be made widely accessible for patients in Europe, Asia and Australia.

The CE Mark is a mandatory conformity marking for certain products sold within the EU and declares that the product meets the essential safety and efficacy requirements of the applicable European directives.

Merck and Sysmex Inostics entered into partnership to develop the testing technology, called OncoBEAM RAS CRC assay, in 2014 and now expect the technology to be widely available by the end of the year.

The test has been shown to have a similar performance to that of conventional tissue-based testing and can be used to determine which patients would benefit from anti-epidermal growth factor receptor (anti-EGFR) therapies, such as Erbitux (cetuximab), as demonstrated by recent data. It is a comprehensive 34-mutation panel that requires only a small blood samples, rather than a tissue biopsy, to determine the mutation status of tumours. It can deliver mutation status results within just a few days.

Rehan Verjee, chief marketing and strategy officer in biopharma at Merck, comments: “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.”

Fernando Andreu, CEO of Sysmex Inostics, says: “Together with Merck, we are advancing biomarker testing in metastatic colorectal cancer, and we are already seeing strong acceptance and uptake of the test in pilot centres, with clinicians globally recognising the clinical value of a blood-based test.”

Sean Murray