CTC analyses has been going full-throttle in the US for several years, and companies have been founded with limited success in getting traction in the research market, much less getting FDA clearance (whether PMA or 510k).

Some market research puts it into the low $B in sales, I do not believe it. Well-established companies in this space are Epic and Menarini (formerly Silicon Biosystems); Angle PLC, BioCept and Fluxion and a few others are out there but struggling. Many companies no longer in business - Cynvenio anyone? Celsee acquired by Bio-Rad.