NEW YORK (GenomeWeb) – Clearbridge BioMedics said today that it has registered its target cell enrichment device, the ClearCell FX1 system, as a Class I medical device with the US Food and Drug Administration.
ClearCell is a label-free, microfluidics-based liquid biopsy device that allows for the enrichment of target cells from blood. The system had previously been CE-marked for in vitro diagnostic use in Europe, and was available in China as a China FDA-approved device. It was commercially launched in 2015.
According to Clearbridge CEO Michael Paumen, the company hopes that achieving registration of the device with the FDA will help accelerate liquid biopsy research and diagnostics development using the platform.
"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,” he said in a statement.