Know Labs is one step closer to bringing its noninvasive glucose monitoring technology to the masses.
In a proof-of-principle study that was conducted in partnership with the Mayo Clinic and which is set to be presented at the American Physiological Society Summit on Friday, the company’s sensor was able to distinguish between a handful of water-based solutions in varying concentrations with complete accuracy—which Know Labs claims will translate into an ability to distinguish between molecules in the body.
“To put this into real-world context: imagine being able to continuously and accurately measure different aspects of your health on a molecular level using a pocket-sized (or smaller) sensor instead of a finger prick or a CGM probe,” CEO Ron Erickson said in a company announcement about the study Friday.
Erickson, who founded the company two decades ago and recently stepped into a third stint as its CEO, noted that the successful study represents an “essential step” toward earning FDA clearance for the tech and, ultimately, bringing it to the market. Further clinical studies of the sensors are still needed before Know Labs can submit the technology for FDA review, but Erickson said in an investor call earlier this year that the devicemaker is aiming to complete all of the remaining pre-submission work by the end of 2023.
Know Labs’ sensors are built around the company’s Body-Radio Frequency Identification, or Bio-RFID, technology. They send out radio waves that travel through the skin to identify and measure molecular signatures in the blood.
So far, the company has embedded the sensors into a wearable wristband, dubbed the UBand, and the palm-sized KnowU device that slips into a user’s pocket. While the former is meant to provide continuous glucose monitoring and the latter offers on-demand blood sugar readings, both are equipped with Bluetooth to automatically transfer their readings to a connected smartphone app.
In the study, which centered on the latter hand-held device, the researchers trained the sensors to recognize solutions that combined isopropyl alcohol, salt and bleach with water. When put to the test in a series of subsequent blinded studies, Know Labs’ tech was able to distinguish between each solution with 100% accuracy. It did so even across varying concentrations of each mixture—the smallest of which weighed in at just 2000 parts per million, which the company compared to a 0.7-milliliter drop of water mixed into a 12-ounce can of soda.
According to the researchers, the results suggest that the sensor could potentially detect solutions in even smaller quantities. Know Labs also noted in its release that the technology’s ability to distinguish between multiple solutions in the study means it could one day be used to measure a variety of substances in the blood, though the company is still planning on first marketing it as a fingerstick-free glucose monitor.
“What we are describing here is truly groundbreaking. This novel application of the Bio-RFID technology to accurately detect and quantify specific molecules in liquid provides strong support for noninvasive monitoring of physiologically and medically relevant analytes in the human body,” James Anderson, M.D., Know Labs’ chief medical officer, said in the announcement.
The study hasn’t yet been published, but is currently going through the peer-editing process, according to Know Labs.