iQ Group Seeks Approval for Diabetes Care Management Biosensor
The real-time biosensor is a small, organic, thin-film transistor diagnostic test that detects accurate salivary glucose measurement for diabetes care management.
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By - Life Science Biosensor Diagnostics (LSBD), a subsidiary of the iQ Group Global, recently filed an FDA Breakthrough Device Designation application for its Saliva Glucose Biosensor for diabetes care management.
Developed at Newcastle University, the real-time biosensor is a small, organic, thin-film transistor diagnostic test that allows accurate salivary glucose measurement at point-of-care.
The iQ Group Global is developing a suite of 150 different diagnostic point-of-care tests using the Biosensor platform through LSBD and its commercial subsidiaries, including a salivary quantitative COVID-19 test, allergen panels, and saliva-based glucose for diabetes patients.
FDA’s Breakthrough Devices Program allows expedited approval for medical devices and products that provide more effective treatment or diagnosis for life-threatening or debilitating diseases or conditions, including diabetes.
The program provides patients and healthcare providers with timely access to these medical devices by speeding up development, assessment, and review.
“The Biosensor Platform unlocks extraordinary opportunities not only for the patient, but also for the healthcare industry,” George Syrmalis, MD, CEO and chairman of The iQ Group Global, said in the announcement.
“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,” Syrmalis continued.
One of the top global players in diabetes care management since 1923 is Eli Lilly and Company.
At the beginning of the COVID-19 pandemic, Eli Lilly and Company dropped insulin costs to $35 a month for individuals with or without commercial insurance. And in September 2021, the company decreased insulin costs again by 40 percent in the US, effective in January 2022.
Additionally, Eli Lilly and Company initiated various trials for its diabetes drugs, including Jardiance and tirzepatide, and took on digital diabetes care management throughout 2021.
Most recently, tirzepatide elicited superior A1C and body weight reductions from baseline in adults with type 2 diabetes and increased cardiovascular risk in a Phase 3 study, SURPASS-4.
For example, 91 percent of participants who received the highest dose of tirzepatide achieved A1C reduction (2.58 percent), while only 51 percent of those who received insulin glargine achieved A1C reduction (1.44 percent).
