The ClearCell® FX System separates and isolates cells in a patient’s blood sample using novel inertia focusing spiral microfluidics in the single-use CTChip® FR. This allows for continuous label-free separation – ie without biochemical labels – of CTCs from blood cells. The larger and denser CTCs are separated from the other blood cells within the spiral biochip due to biomechanical differences – and are then focused into an enriched cell ‘stream’. These cell streams are channeled and collected into an enriched sample, which can be used for pathology diagnostic tests such as mutation testing for targeted therapies.
John Pritchard, head of diagnostics at Cambridge Consultants, said: “This has been a collaborative merging of our extensive experience in diagnostic device development and Clearbridge BioMedics’ expertise in cancer research and diagnostics – and it’s led to breakthrough technology that will have a huge impact on a lot of people’s lives. Our systems engineering approach, coupled with our skills in fluidics, software and compliance, has enabled us to work quickly and efficiently with Clearbridge BioMedics – even though we are thousands of miles apart.”
Clearbridge BioMedics also worked in collaboration with the National University of Singapore and the Singapore-MIT Alliance for Research and Technology (SMART) Center. The new system – which has been designed for both research and diagnostics applications – will be undergoing regulatory approval in the US and Europe.
Johnson Chen, co-founder and managing director of Clearbridge BioMedics, said: “Once approved, it will be one of the world’s first label-free CTC enrichment systems for diagnostic use. Clearbridge BioMedics believes this system will be an ideal companion diagnostic system that complements various cancer therapies.”
Set up in late 2009, Clearbridge BioMedics is a spin-off company from the National University of Singapore. The firm’s first-generation ClearCell® System – which was launched for the cancer research market in 2011 – was one of the first non-biomarker-based systems commercially available to detect, isolate and retrieve CTCs from blood.