U.S. FDA enlists Clearbridge Biomedic’s ClearCell FX1 system

Clearbridge Biomedics announced successful registration of ClearCell® FX1 system, its target cell- enrichment device with the U.S FDA as a class I Medical device for to diagnose in-vitro providing a liquid biopsy solution for clinical research in the United States. Having attained CE marking in an in- vitro diagnostic medical device in Europe and China’s Class I Medical device sanctioned by Europe and China FDA. The system entails the innovative microfluidics CTChip® to separate and retrieve intact, viable target cells from a patient’s blood sample. The system was commercially available from 2015, advocating innumerable liquid biopsy studies. In 2017, it was selected to partake in the acclaimed  CANCER-ID consortium, where known cancer institutes and researchers use the technology to better understand the underlying biology of circulating tumor cells (CTCs) eventually offering more depth into the disease ensuring innovative cancer therapies accelerating patient management protocols. Undisputed processing of both VTCs and circulating tumor DNA from the same patient sample for future interpretation paving way for conclusive cancer profiling.

Michael Paumen, CEO of Clearbridge BioMedics said “We believe, the ClearCell® FX1 System will play a critical role in the development of new therapies by providing label-free, intact and viable cells for analysis. Successfully listing the unit with the U.S. FDA for in vitro diagnostic purposes will accelerate research and the adoption of diagnostics from the tumor cells obtained. We will continue to work with our partners and the authorities to further validate the system, for use in cancer diagnostics, personalized therapy management, and patient monitoring.”