By Clinical Research News Staff 

June 2, 2025 | After 15 years of development, Stanford University's Tom Soh is preparing to take his biosensor technology from laboratory rats to human volunteers. The device, which can continuously monitor molecules in flowing blood for up to seven days, represents a potential paradigm shift in clinical medicine. 

From Concept to Clinical Reality 

SENSBIT (Stable Electrochemical Nanostructured Sensor for Blood In situ Tracking) emerged from Soh's frustration with medicine's reactive approach to health monitoring. His solution: a microfabricated soft needle equipped with nanostructured electrodes that can be placed into a vein or under the skin to provide real-time molecular surveillance. 

The technology's journey to human testing has been marked by incremental breakthroughs. Previous biosensors of this type could survive in blood vessels for only about 11 hours before failing. Soh's team extended that to seven days—an order of magnitude improvement that makes clinical applications feasible. In laboratory studies, the sensor retained over 60% of its effectiveness after a week implanted in live rats and over 70% of its signal strength after a month in human serum. 

Preparing for Human Testing 

The path to human trials has required solving complex biocompatibility challenges. The sensor's bioinspired design mimics the protective microvilli lining the gut wall, using a nanoporous gold surface decorated with an inert polymer to shield the device from the harsh environment of whole blood. This coating acts as a size exclusion filter, blocking large blood components like red blood cells and sticky proteins while allowing target molecules to reach the sensor. 

"Right now, we are trying to get IRB [institutional review board] approval to show that our sensor poses non-significant risk to healthy volunteers," Soh explains. The team expects to begin first-in-human trials within the next 12 to 18 months, a timeline that reflects both the promise of the technology and the rigorous safety requirements for implantable medical devices. 

What the Trials Will Test 

The initial human studies will likely focus on demonstrating safety and basic functionality rather than specific clinical applications. The team has already proven the concept using kanamycin, an aminoglycoside antibiotic that's easily detected because it's not naturally produced by the body. This straightforward target provides a clear signal that can validate the sensor's performance in human blood. 

The trials will need to demonstrate that the device can operate safely in human volunteers without causing adverse reactions or interfering with normal physiological processes. Success will be measured not just by the sensor's ability to detect target molecules, but by its biocompatibility and the absence of complications over the monitoring period. 

Beyond the Initial Trials 

If the human trials succeed, they will open the door to a new era of continuous biomonitoring. The modular design of SENSBIT means it can be adapted to track virtually any molecule of interest, from therapeutic drugs to disease biomarkers. Future applications could include monitoring hormone levels in endocrine disorders, tracking inflammatory markers in autoimmune diseases, or detecting the earliest molecular signatures of cancer. 

Perhaps most ambitiously, Soh envisions using the technology to "listen in" on immune cell communications. When the body encounters infections, immune cells coordinate their response through cytokines and other signaling molecules. Real-time monitoring of these molecular conversations could enable doctors to detect infections before symptoms appear and tailor treatments to specific pathogens. 

For Deborah Borfitz’s complete story, visit Diagnostics World News.