Country for PR: Australia
Contributor: Medianet International
Tuesday, October 19 2021 - 16:41
AsiaNet
FDA Pre-Submission for Saliva-Based Glucose Test to Replace Invasive Finger-Prick
SYDNEY, Oct. 19 /Medianet International-AsiaNet/ --

The iQ Group Global Ltd (NSX.IQG), on behalf of its subsidiary, Life Science 
Biosensor Diagnostics Pty Ltd (LSBD), is pleased to announce that one of its 
licensees, GBS Inc (Nasdaq: GBS); a life sciences company operating in the Asia 
Pacific region, under license from LSBD, to commercialize its non-invasive, 
real-time Glucose Salivary test; has filed a Pre-Submission package with the 
United States (US) Food and Drug Administration (FDA).

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 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 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, 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 non-invasive 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," CEO and Chairman of The iQ Group Global, Dr. George 
Syrmalis, said.

"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."

About The iQ Group Global Limited (NSX: IQG)
The iQ Group Global Ltd is a life science company that finds, funds and 
develops bioscience discoveries to create life-changing medical innovations.

About The iQ Group Global
The iQ Group Global is a group of companies that find, fund and develop 
bioscience discoveries to create life-changing medical innovations. Recognised 
by The Australian Financial Review for the second consecutive year as one of 
the country’s Most Innovative Companies in 2020, The iQ Group Global’s flagship 
innovations include the Biosensor Platform and TEX Core, a first-in-class 
oncology drug platform with the ability to develop a pipeline of novel oncology 
compounds. Visit our website: theiqgroupglobal.com

About GBS Inc.
GBS Inc. is a biosensor diagnostic technology company operating under license 
from LSBD Pty Ltd and is focused on commercialising the Saliva Glucose 
Biosensor in the Asia Pacific Region.

SOURCE: The iQ Group Global Ltd.