Life sciences and medical technology company Life Science Biosensor Diagnostics (LSBD) has filed an application with the U.S Food and Drug Administration (FDA) for Breakthrough Devices Designation for its Saliva Glucose Biosensor.
The FDA Program will provide LSBD— a subsidiary of The iQ Group Global—with an expedited path toward regulatory approval for its non-invasive, real-time saliva glucose test.
The IQ Group Global—through LSBD and its commercial subsidiaries and licensees, BioSensX Global Inc. and GBS Inc.—are developing a suite of 150 different diagnostic point-of-care tests, including a salivary quantitative SARS-CoV-2 test, allergen panels, and saliva-based glucose; for patients living with diabetes; using the Biosensor Platform.
The Biosensor is a small organic thin-film transistor diagnostic test, developed at Newcastle University, that enables accurate salivary glucose measurement in real-time at point-of-care.
The FD’s Breakthrough Devices Program allows expedited approval for medical devices and products that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions, like diabetes. The purpose of the program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review.
“We are looking forward to working with the FDA so we can commence clinical trials as soon as possible and make this innovative device accessible to the people who need it globally. The Biosensor Platform unlocks extraordinary opportunities not only for the patient, but also for the healthcare industry,” says George Syrmalis, PhD, CEO and Chairman of The iQ Group Global.
Featured image: The Biosensor is a small organic thin-film transistor diagnostic test that enables accurate salivary glucose measurement in real-time at point-of-care. Photo: Life Science Biosensor Diagnostics