Merck and Biocartis partner on new biomarker test for colorectal cancer

pharmafile | January 7, 2016 | News story | Research and Development |  BRAF mutations, Diagnostics, Erbitux, Merck, RAS metations, diagnostic tests, metastic colorectal cancer 

Merck has signed a collaboration agreement with diagnostics company Biocartis for the development and commercialisation of a new test for patients with metastatic colorectal cancer.

The test will be developed on Biocartis’ fully automated molecular diagnostics system, Idylla, which is designed to offer accurate and reliable molecular information using a liquid biopsy.

Biocartis’ Idylla system is able to detect a greater number of RAS mutations than the majority of tests available today. The new test to be developed with Merck will also provide a BRAF V600 mutation analysis, allowing clinicians to evaluate BRAF and RAS mutation status simultaneously. The presence of both mutations generally indicates the cancer is less likely to respond to treatment.

The intention is to help clinical practices perform easier tests, irrespective of their experience or skill in this field. The test will be designed to require less than two minutes of hands-on time and a turnaround time of approximately two hours.

Analysis and understanding of the individual biomarker status of metastatic colorectal cancer (mCRC) patients could allow healthcare professionals to make more timely and accurate decisions as to which treatment the patient should receive, and enable the use of personalised medicines appropriate to the individual patient.

Approximately half of patients with mCRC have RAS wild-type tumours, and half have RAS mutant tumours. Anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Merck’s Erbitux (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.

“Through this collaboration, our desire is to have more metastatic colorectal cancer patients gain access to liquid biopsy RAS testing, regardless of their geographical location,” says Rehan Verjee, chief marketing and strategy officer of Merck’s biopharma business.

“As the first pharmaceutical company to collaborate with multiple diagnostic providers of liquid biopsy RAS testing, we are living our commitment to supporting patients and physicians by going beyond treatment. The Biocartis technology will be complementary to other technology previously developed, and will allow for liquid biopsy RAS offerings to a wide range of lab segments, regardless of size and expertise levels.”

Rudi Pauwels, chief executive of Biocartis add: “Today, complex diagnostic laboratory infrastructure and specialised expertise requirements are important barriers when it comes to the implementation of personalised medicine on a global scale.”  

Merck and Biocartis plan to implement the Idylla liquid biopsy RAS test in numerous medical centres worldwide, but excluding the US, China and Japan. The test will be available for research use only in the second half of 2016.

Joel Levy