Merck, a leading science and technology company, announced that a new liquid biopsy RAS biomarker test, which they are co-developing and commercializing with Sysmex Inostics, has been granted CE Mark approval.

This test will now be made widely accessible for patients with metastatic colorectal cancer (mCRC) in Europe, Asia and Australia.

The testing technology, OncoBEAM® RAS CRC assay, has been shown to have a similar performance to that of conventional tissue-based testing[1-3] 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.[4-8]

"In keeping with our philosophy of patient focus, we strive to evaluate all aspects of the patient journey, to focus our efforts on projects that improve treatment experience and outcomes for the patients," said Rehan Verjee, Chief Marketing and Strategy Officer of Merck’s biopharma business.

"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."

"We have achieved a significant milestone with the CE Mark of the OncoBEAM® RAS colorectal cancer assay," said Fernando Andreu, CEO of Sysmex Inostics. "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 centers, with clinicians globally recognizing the clinical value of a blood-based test."

The liquid biopsy RAS biomarker test is a comprehensive 34-mutation panel that is based on the BEAMing (Beads, Emulsion, Amplification and Magnetics) technology.

The test only requires a small blood sample (10 ml), rather than a tissue biopsy, to determine the mutation status of tumors.[9] The test has the potential to provide mutation status results within days, which can help guide quicker treatment decisions.[9]

"As the first test center to use the liquid biopsy RAS biomarker testing technology we have seen firsthand how this technology has advanced treatment decision-making," said Professor Josep Tabernero, Director Head of the Medical Oncology Department of Vall d’Hebron University Hospital, Spain.

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

Merck and Sysmex Inostics entered into an agreement to co-develop and commercialize the liquid biopsy test on May 19, 2014 and opened the first test center, for research use only, at the Vall d’Hebron Institute of Oncology in Barcelona, Spain on February 20, 2015.

Now with the CE Mark, the liquid biopsy RAS biomarker testing technology is expected to be widely implemented across Europe, Asia, Latin America and Australia by the end of 2016.

Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.[10]

Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.[4-8]