Recent clinical trials of microfluidic devices

After I heard about a clinical trial for a microfluidic device that detects circulating cancer cells, I started wondering how many other microfluidic devices are in clinical trials. A quick search turned up only seven studies (and two of those were withdrawn). Interestingly, five of the seven trials have some connection to the University of Michigan, which appears to be a leader in pursuing commercialization of microfluidics.

Systems for in vitro embryo development InCept Biosystems (co-founded by Shuichi Takayama of the University of Michigan) has two active clinical trials (Phase I and Phase II) testing their SMART device, which uses microfluidics to create an in-vivo-like environment for in vitro embryo culture.

Diagnostics for pathogen identification A big problem in treating infection is identifying the infecting organism—the conventional culture tests take so long that doctors often prescribe antibiotics without knowing what bacteria they’re up against. If a fast, reliable method were available to identify the pathogen, doctors could prescribe antibiotics known to kill that bug, potentially speeding recovery and reducing overuse of antibiotics (hence reducing the generation of antibiotic resistance). lists three studies on microfluidic diagnostic devices for pathogen detection, although two have been withdrawn. The active study is being conducted by Peking University People’s Hospital and hopes to demonstrate a rapid detection system for bacteria typically found in pneumonia. The two withdrawn trials conducted by the University of Michigan were originally intended to rapidly detect Group B streptococcus neonatal infections, but both were discontinued with the explanation that “HandyLab device did not work for the science.” I’d love to find out what went wrong with the HandyLab device and if Becton Dickinson is still developing that product.

Diagnostics for periodontal disease Finally, the University of Michigan is also testing a device for rapid diagnosis of periodontal disease. I’m curious about the need for such a device—maybe I’ll ask on my next trip to the dentist.