Clearbridge BioMedics has achieved ISO13485 certification for the development of cell-based in-vitro diagnostic devices and recently launched its ClearCell™ System, for the cancer research market. This is one of the world’s first commercially available systems that can successfully isolate circulating tumour cells (CTC) from blood using biomechanical properties. The ClearCell System, which consists of the proprietary CTChip®, can retrieve intact and viable CTCs in their native states, without the use of antibodies or magnetic beads. This will enable cancer researchers to better understand the relationship between such cells and mechanisms of cancer. The ClearCell System will be on showcase at the American Association for Cancer Research annual meeting, from March 31 to April 4 in Chicago.

"Through our ClearCell System, we are now entering the diverse and growing cancer research market," said Johnson Chen, co-founder Clearbridge BioMedics. “This in turn will have an impact on improving new therapies for cancer patients. We are targeting cancer research organizations and hospitals, which regularly need to isolate and analyze CTCs. We believe that ClearCell will be of particular interest to the research community, since it can retrieve viable and intact cells. Moving forward, we are working towards the development of the ClearCell System for in-vitro diagnostic applications.”

ISO 13485 is a comprehensive management system for the design and manufacture of medical devices. This certification has become the model standard for the medical devices industry and Clearbridge BioMedics is one of the few companies, within the CTC sector, to have met this Quality Management System. By complying with this regulatory requirement, Clearbridge BioMedics demonstrates its commitment to rigorous product development standards.

Source: Clearbridge BioMedics