Belgium-based molecular diagnostics firm Biocartis has signed a collaboration agreement with Merck to develop and commercialise a new liquid biopsy RAS biomarker test for patients with metastatic colorectal cancer (mCRC).
Based on Biocartis’, fully automated molecular diagnostics system, Idylla, the test aims to support clinical practise in performing integrated liquid biopsy RAS biomarker tests independently of the laboratories’ volume of testing or level of expertise.
Idylla is designed to provide accurate and reliable molecular information from any biological sample in any setting.
Merck biopharma business chief marketing and strategy officer Rehan Verjee said: "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.
"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."
Idylla is a fully automated sample-to-result polymerase chain reaction-based (PCR) molecular diagnostics system that is designed to offer real-time, reliable and sensitive molecular diagnostic tests.
The Idylla RAS test, which includes two Idylla cartridges, will be designed to detect an extended panel of RAS mutations.
In addition, the new test will provide a BRAF V600 mutation analysis directly integrated with the Idylla RAS test to allow clinicians to evaluate BRAF and RAS mutation status simultaneously.
The company noted that based on a direct sample of 2ml of blood plasma, the test aims to provide high sensitivity and ease-of-use.
The test will require less than two minutes of hands-on time and a turnaround time of two hours, allowing clinical decision making in a timely manner.
Both firms plan to implement the Idylla liquid biopsy RAS test in several medical centres worldwide, excluding the US, China and Japan.
The test is expected to be available for research use only in the second half of this year and is planned to be submitted for a CE Mark.