Country for PR: Australia
Contributor: Medianet International
Thursday, December 16 2021 - 00:01
AsiaNet
FDA Breakthrough Devices Designation Application to Fast-Track Painful Finger-Prick Alternative for People Living with Diabetes
SYDNEY, Australia, Dec. 15, 2021 /Medianet International-AsiaNet/ --

Life Science Biosensor Diagnostics Pty Ltd (LSBD), a life sciences and medical 
technology company and subsidiary of The iQ Group Global, announced it has 
filed an application with the U.S Food and Drug Administration (FDA) for 
Breakthrough Devices Designation for its Saliva Glucose Biosensor. 

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The FDA Program will provide LSBD 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," 
CEO and Chairman of The iQ Group Global, Dr. George Syrmalis, said.

"There are more than 400 million people living with various stages of diabetes 
globally that have no alternative other than a painful and invasive blood 
glucose test, that often has to be administered multiple times per day. Our 
technology negates the need for this often-traumatic experience by using saliva 
instead of blood."

About Life Science Biosensor Diagnostics Pty Ltd (LSBD)
Life Sciences Biosensor Diagnostics Pty Ltd (LSBD) is the company that owns and 
manages the intellectual property of the diagnostic Biosensor Platform.

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. Recognized 
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 
(https://theiqgroupglobal.com)

Media Contact:
James Gorman
+61 (0)2 8239 5400
james.gorman@theiqgroupglobal.com


SOURCE: The iQ Group Global Ltd.