NEW YORK (GenomeWeb) – Belgian molecular diagnostics firm Biocartis announced today that it has signed an agreement with Germany's Merck to develop and commercialize a new liquid biopsy-based RAS biomarker test for metastatic colorectal cancer based on its Idylla PCR-based diagnostics platform.
According to Biocartis, the new test will comprise two Idylla cartridges and be designed to detect an extended panel of RAS mutations while also providing a BRAF V600 mutation analysis, allowing clinicians to evaluate the mutation status of both biomarker types simultaneously.
The companies anticipate testing the Idylla liquid biopsy RAS test in multiple international clinical centers outside of the US, China, and Japan, and making it available for research use only in the second half of this year. The test is expected to be submitted for CE marking shortly thereafter, they said.
"Today, complex diagnostic laboratory infrastructure and specialized expertise requirements are important barriers when it comes to the implementation of personalized medicine on a global scale," Biocartis CEO Rudi Pauwels said in a statement. "After having already launched solid biopsy RAS tests, the Idylla liquid biopsy RAS test is a logical next step in our rapidly expanding menu of oncology tests."
Late last year, Biocartis received a $1.5 million grant from the Flemish Agency for Innovation by Science and Technology to develop liquid biopsy versions of its solid tumor BRAF and KRAS diagnostics for melanoma and colorectal cancer.
"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," Rehan Verjee, chief marketing and strategy officer for Merck's biopharma business, added in the statement. "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."
Merck currently markets the EGRF inhibitor Erbitux (cetuximab) for metastatic colorectal cancer, among other oncology indications, outside the US and Canada.