Bio-RFID Tech Yields Blood Glucose Readings Comparable to FDA-Cleared Devices

Know Labs Inc., an emerging leader in non-invasive medical diagnostics, has published a new report on its non-invasive platform technology, Bio-RFID, comparing its clinical accuracy to U.S. Food and Drug Administration (FDA)-cleared glucose monitoring devices that are currently available in the market.

For these latest tests, human subjects placed their arms on a Bio-RFID sensor and their blood glucose levels were measured every five minutes over a period of two hours. Concurrent readings were taken with an Accu-Chek fingerstick device and with two continuous glucose monitoring devices, Abbott FreeStyle Libre and Dexcom G6, which allowed the calculation of Bio-RFID’s MARD (mean absolute relative difference). MARD is the most common metric used to assess the performance of glucose monitoring systems, with a low percentage indicating the glucose readings are close to the reference glucose value, validating the device’s accuracy. Values under 10 percent are regarded to have good analytical performance. The Bio-RFID average MARD was between 5.3 percent and 6.7 percent when compared with the FDA-approved devices used in the study, which confirms that Bio-RFID can offer the high-level of clinical accuracy required by medical diagnostics devices.

“The accuracy achieved by Bio-RFID showcased in this report is supported by the hundreds of tests that our research and development team has conducted in the last few years and the continued optimization of our AI-powered algorithm. I couldn’t be prouder of the work done by our team,” said Phil Bosua, Know Labs CEO and Bio-RFID inventor. “This data confirms that Know Labs’ family of products can be an accurate, cost-effective and non-invasive alternative to the current FDA-cleared glucose monitoring devices in the market, and to the painful, inconvenient fingersticks still used by many millions of people with diabetes.”

Know Labs miniaturized the Bio-RFID sensor, taking it from a 3 foot by 3 foot circuit board to a small device that fits in a pocket. The Bio-RFID sensor is the core component of Know Labs’ KnowU and UBand, two non-invasive glucose monitoring devices that will address different market segments. KnowU offers on-demand and on-the-go use while the UBand addresses the continuous and wearable need.

“Our miniaturization efforts combined with our powerful predictive diagnostics AI brings us much closer to market,” said Ron Erickson, Know Labs chairman and founder. “Right now, we are focused on getting our human testing protocol approved by an independent review board so we can begin internal clinical studies.”

Know Labs Inc. is a public company whose technology uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. The company refers to its technology as Bio-RFID. The Bio-RFID technology can be integrated into a variety of wearable, mobile, or bench-top form factors. This patented and patent-pending technology makes it possible to effectively conduct analyses that could only previously be performed by invasive and/or expensive and time-consuming lab-based tests. The first application of the Bio-RFID technology will be in a product marketed as a glucose monitor. It will provide the user with real-time information on their blood glucose levels.