Real-Time Glucose Saliva-Based Test to Replace Invasive Finger-Prick Testing for Diabetic Patients

GBS, Inc. (New York, NY, USA) is developing a saliva-based glucose test on the Biosensor Platform to be used in the point-of-care setting. The company has filed a Pre-Submission package with the US Food and Drug Administration (FDA) to confirm that it is following the proper steps to conduct the clinical studies enabling it to develop the glucose biosensor according to the FDA regulatory standards. The Biosensor Platform is a small, printable organic strip designed to put the power of accurate, timely diagnosis in the hands of patients and their primary health practitioners. By altering the detection element depending on the specific analyte of interest, GBS has the ability to produce a whole portfolio of non-invasive, real-time, saliva-based diagnostic tests. Because both the core OTFT sensing element and the mechanism of action remains the same, tests developed from the Biosensor Platform have the potential to be printed at scale, at a low cost.

The real-time saliva-based glucose test offers a pain-free option to current testing methods by using an organic thin film transistor, incorporating Glucose Oxidase (GOX) as the recognition element to initiate an electrochemical reaction that produces an electrical signal to display glucose measurements in real-time on a mobile app or dedicated device. The Saliva Glucose Biosensor is the first non-invasive, saliva-based glucose test for diabetes management that measures glucose in saliva, not blood. The innovative technology will free people living with diabetes from having to use painful and invasive blood monitoring devices to manage their condition, giving them a better quality of life.

The Saliva Glucose Biosensor System will allow the patient to achieve better glucose control through a practical understanding of lifestyle factors that affect glucose levels, thereby helping prevent or delay diabetes complications and ultimately personalizing diabetes management. At the patient’s or authorized carer’s requirement, the patient data can be disseminated to a remote caregiver, a service for consultation or to any other individual with whom the patient chooses to share their glucose level measurements. Through the regulatory process GBS intends to demonstrate that the Saliva Glucose Biosensor can be used as a point of care self-test, indicated for the management of diabetes, non-adjunctive to blood glucose testing for diabetes treatment decisions.

 “The number of people living with diabetes is expected to increase to 700 million by 2045 and in 2019 an estimated 1.5 million deaths were directly caused by this disease, so it is imperative people living with diabetes have the means to regularly monitor and manage their glucose levels in a painless and easy way,” said Harry Simeonidis Chief Executive Officer of GBS. “It has always been our mission to create simple to use, life-changing diagnostics that can be put into the hands of people who need them the most, and our world-first Biosensor technology is the first step in fulfilling that mission.”

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