20 October 2021 | News
Announces FDA pre-submission for saliva-based glucose test
image credit- GBS Inc.
Australia-based iQ Group Global, on behalf of its subsidiary, Life Science Biosensor Diagnostics Pty Ltd (LSBD), has announced that one of its licensees, GBS Inc, 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 objective of the proposed clinical plan is to correlate saliva glucose to plasma glucose; develop and confirm the Biosensor algorithm; and validate, in accordance with FDA specifications, the Saliva Glucose Biosensor system.
GBS Inc., a biosensor diagnostic technology company operating under license from LSBD, is focused on commercialising the Saliva Glucose Biosensor in the Asia Pacific Region.