Know Labs Expands Non-Invasive Diagnostics IP With New Patent

Know Labs Inc. has been granted a new foundational patent that equates the company’s Bio-RFID diagnostic technology to a current reference standard for glucose monitoring, widely used by diabetes researchers, hospital labs, and glucose meter manufacturers, and establishes a specific, superior benchmark range of clinical accuracy, known as the MARD or Mean Absolute Relative Difference.

The new patent extends the Know Labs IP portfolio to nearly 90 patents issued and pending, reinforcing the company’s position as the top worldwide IP holder in non-invasive blood glucose monitoring.

“Intellectual property development is a critical pillar of our success,” Know Labs Founder/Chairman Ron Erickson said. “We make significant investments in the strategic development of our IP Portfolio, which creates long-term value for our shareholders, improves our competitive position and accelerates our efforts to bring the first FDA-cleared, truly non-invasive glucose monitoring device to the market.”

U.S. Patent No. 11,529,077, titled “High Performance Glucose Sensor,” explicitly designates a 5% to 9.9% MARD range for Know Lab’s non-invasive diagnostics technology platform. MARD is an industry and U.S. Food and Drug Administration (FDA)-accepted benchmark of clinical accuracy. The range patented for Know Labs’ Bio-RFID platform is equal to or superior to the MARD readings of any FDA-cleared blood glucose monitoring products, highlighting its importance for Know Labs’ future and its IP portfolio. 

Know Labs Bio-RFID technology approaches blood glucose reading very differently than FDA-cleared devices currently available on the market. Radio frequency spectroscopy, enhanced by time-frequency synchronization and decoupled antenna designs, allows the Bio-RFID technology to collect a massive amount of data signals across real time glucose concentrations in the interstitial fluid, capillary and venous blood, and cellular tissue. Based on internal estimates, at 16mW at 2.5 GHz, Know Labs’ sensor penetrates to an average 0.5 inches. In contrast, current micro-filaments used by minimally invasive devices, such as Dexcom G6 and G7, and Abbott FreeStyle Libre systems are limited to readings of only the interstitial fluid typically within 0.2 inches of the skin surface.

The patent also states that Know Labs’ non-invasive diagnostic technology could become the new reference standard for glucose testing. The current “gold standard,” the YSITM Glucose Analyzer, measures only capillary blood. “The high accuracy of the [Know Labs] non-invasive glucose sensor described herein, when compared to lower accuracy glucose sensors such as minimally invasive CGMs and fingerstick glucose sensors, means that the [Know Labs’] non-invasive glucose sensor can be used as a standard or reference sensor against which the accuracy of other glucose sensors are gauged. In one embodiment, readings from the non-invasive glucose sensor described herein can be used in place of readings obtained by a YSI glucose analyzer,” the patent reads.

“We believe this is the first and only patent granted with a MARD range in its claims,” Erickson said. “This is a significant milestone for Know Labs and for the non-invasive glucose monitoring industry, as it sets a new benchmark for MARD among all glucose sensors, invasive or not. We remain confident in our plans as we continue executing toward the FDA clearance process. To build something that has never been done before, we need to approach the problem from a different angle. This patent shows we are doing that and validates that we are on the right track. There is more to be done. We believe our technology platform will transform the medical diagnostics industry and significantly improve the lives of millions of people worldwide.”

Know Labs’ Technology is in development. Internal testing has demonstrated that Bio-RFID can deliver a MARD under 10%. The company continues to test and refine Bio-RFID’s hardware and algorithms in preparation for the FDA clearance process. 

Know Labs Inc.’s 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 and claims it can be integrated into various wearable, mobile or bench-top form factors. This patented and patent-pending technology makes it possible to effectively identify and monitor analytes that could only previously be performed by invasive and/or expensive and time-consuming lab-based tests. The first application of Know Labs’s Bio-RFID technology will be in a product marketed as a non-invasive glucose monitor. It will provide the user with real-time information on blood glucose levels.