To commercialize its noninvasive, real-time glucose salivary test, GBS Inc., a life sciences company operating in the Asia Pacific region, has filed a Pre-Submission package with the U.S. Food and Drug Administration (FDA). GBS Inc., developers of the Saliva Glucose Biosensor system, is a biosensor diagnostic technology company operating under license from Life Science Biosensor Diagnostics Pty Ltd (LSBD), a subsidiary of Sydney-based iQ Group Global Ltd.
The purpose of this Pre-Submission is to confirm with the FDA the clinical trial design, including trial objectives. This interaction will allow the FDA to review the company’s clinical trial plans and protocols, while also providing a forum for feedback on these clinical studies as it pursues regulatory approval.
The primary objectives of the proposed clinical plan are as follows:
- Correlate saliva glucose to plasma glucose.
- Develop and confirm the Biosensor algorithm.
- Validate, in accordance with FDA specifications, the Saliva Glucose Biosensor system.
As per the license agreement between LSBD and GBS, it is foreseen that any Biosensor intellectual property (IP) generated by GBS-funded Biosensor research and development will flow on to LSBD. LSBD is the IP owner and beneficial owner of all Biosensor IP generated by GBS biosensor programs. LSBD has also licensed its Biosensor IP to its fully owned subsidiary BioSensX Global Inc., which is the worldwide licensee, with exception of the GBS Asia Pacific (APAC) region. It has also been agreed between LSBD and GBS that LSBD will be receiving royalties from their APAC sales revenue.
The iQ Group Global (IQG), through LSBD and its commercial subsidiary BioSensX Global Inc., is developing a suite of 148 different diagnostic point-of-care tests, including allergen panels and the saliva-based glucose test on the Biosensor platform to be used by patients living with diabetes. The company intends to provide people living with diabetes a noninvasive solution to the current finger-prick glucose testing.
“GBS anticipates securing strategic partnership opportunities for sales and distribution in the APAC region by the end of the financial year 2022, and with this FDA Pre-Submission, LSBD expects to receive its first royalties (minimum 13%) in near term,” says George Syrmalis, PhD, CEO and chairman of the iQ Group Global. “This is an exciting time for LSBD and its parent companies, IQG and IQX, as the APAC market enumerates approximately 164 million people suffering from diabetes.”
Based in Sydney, the iQ Group Global Ltd is a life science company that finds, funds, and develops bioscience discoveries for medical innovations.
For more information, visit IQ Group Global.