The iQ Group Global has announced the filing of a pre-submission package to the US Food and Drug Administration (FDA) for a non-invasive, real-time Glucose Salivary test.
The submission was made by life sciences company GBS, a licensee of iQ Group subsidiary Life Science Biosensor Diagnostics (LSBD).
Through the pre-submission, the company intends to validate the trial design, including the goals of the study, with the FDA.
Through this communication, the FDA will assess the clinical trial plans and protocols of iQ Group and offer a setting for feedback on these studies as it seeks regulatory approval.
The primary goals of the proposed clinical plan are to link saliva glucose to plasma glucose as well as create and validate the biosensor algorithm.
The validation of the Saliva Glucose Biosensor system will be in line with the requirements of the FDA.
Through LSBD and its commercial subsidiary, BioSensX Global, the IQ Group is creating a set of 148 diagnostic point-of-care tests, including allergen panels and the saliva-based glucose test.
Based on the Biosensor platform, the salivary test could potentially be utilised by people living with diabetes as a non-invasive alternative to the current finger-prick glucose testing.
The iQ Group Global CEO and chairman Dr George Syrmalis said: “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.
“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.”
According to the licence agreement signed by LSBD and GBS, any Biosensor intellectual property (IP) created using GBS-funded Biosensor research and development will flow on to the former.
Under the deal, all Biosensor IP generated by GBS biosensor programmes belongs to LSBD, which is the IP and beneficial owner.