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FDA Pre-Submission for Saliva-Based Glucose Test to Replace Invasive Finger-Prick

  • Written by PR Newswire

SYDNEY, Oct. 19, 2021 /PRNewswire/ -- 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:

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.

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Source: The iQ Group Global Ltd.

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