Merck Serono, the biopharmaceutical business of Merck, has announced the opening of the first liquid biopsy RAS biomarker testing center in Vall d'Hebron's Institute of Oncology, Barcelona, Spain, and initially will test patients as part of its research program. This is an important milestone in making the new liquid biopsy RAS test available to patients with metastatic colorectal cancer (mCRC), and a significant step forward in Merck Serono's collaboration with Sysmex Inostics, a Germany-based molecular diagnostic company.
The liquid biopsy method, also known as blood-based biomarker testing, is a simplified and rapid approach for determining the RAS (KRAS and NRAS) mutation status of tumors, as it requires a single blood draw, rather than a tissue biopsy or surgical procedure.
The liquid biopsy RAS biomarker test will help to advance precision medicine, and also has the potential to provide mutation status results within days, helping to guide treatment decisions. Approximately half of patients with mCRC present with tumors with RAS mutations. Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody therapies, such as Erbitux (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.
The liquid biopsy RAS biomarker test is expected to receive its European Conformity approval (CE mark) in the coming months, making it accessible to a wider population of mCRC patients. The test will then be implemented in numerous medical centers across the world. The Vall d'Hebron Institute of Oncology will be the first test center of its kind, with further laboratories to be established throughout 2015, including in Australia, France, Germany, Italy and the U.K., among others.
Vall d'Hebron's Institute of Oncology will use blood samples from mCRC patients to advance research into RAS biomarkers. The ability to test for these mutations at Vall d'Hebron with a potentially quicker and easier testing method could improve the standard of care for patients.
"As patients with metastatic colorectal cancer (mCRC) can respond differently to various treatments, it is important to understand more about the tumor, especially its biology and genetics," said ProfessorJosep Tabernero, director of the Vall d'Hebron Institute of Oncology. "Once this liquid biopsy RAS biomarker test has received its CE mark, it will become an important advance in testing mCRC patients and be a useful tool for treatment decisions. The liquid biopsy method can potentially save time, compared with current tissue-based RAS testing, and spares patients from a tissue biopsy or surgical procedure. We will only need a sample of blood, and we can then potentially provide results in two to three days."