GBS Inc. (NASDAQ: GBS) stock declined by 23.17% at last close however the GBS stock price moves up during pre-market by 15.08%. GBS Inc. is a life sciences firm that creates non-invasive, real-time screening and medical tests for individuals and their primary care physicians.
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GBS stock’ Recent Development
GBS Inc. has announced that in partnership with Life Science Biosensor Diagnostics Pty Ltd (LSBD), the licensor of the Rapid Saliva Glucose Test, LSBD has submitted a request for Breakthrough Device Designation with the U.S. Food and Drug Administration (FDA).
The goal of the FDA Devices Breakthrough Program application is to give LSBD a faster road to regulatory clearance for their non-invasive, real-time Saliva Glucose test.
For the Asia Pacific (APAC) Region, GBS is the license holder of LSBD’s Biosensor Platform. GBS also has 50% of BiosensX (North America) Inc., which is the North American Region’s licensee. The Rapid Saliva Glucose Assays are part of the Biosensor Platform, which also comprises a suite of 150 distinct diagnostic point-of-care tests. The Biosensor is a tiny organic thin-film transistor diagnostic test that was created at Newcastle University with the goal of allowing reliable salivary glucose monitoring in real-time at the moment.
Dr. Steven Boyages, the Interim GBS CEO and Chairman of the Board commented that,
They think that this technology will cover a significant and critical gap in examining the effectiveness of the millions of diabetics worldwide. This disparity is especially visible in the middle of the COVID-19 epidemic since poor diabetes control worsens morbidity and death from infection.
The FDA’s Breakthrough Devices Program provides for the accelerated approval of medical equipment and goods that enable more appropriate cures or diagnoses for life-threatening or permanently disabling illnesses or disorders, such as diabetes. The Program’s goal is to give patients and health care professionals early access to innovative medical devices by accelerating their development, assessment, and review.