GBS Inc. (Nasdaq: GBS), a life sciences company developing non-invasive, real-time diagnostic testing for patients and their primary health practitioners at point-of-care, today announced completion of sample collection and analysis of glucose in oral fluid and blood samples from their clinical study at the Diabetes Research Institute of Sutter Health’s Mills-Peninsula Medical Center (MPMC) in San Mateo, California. GBS will perform subsequent statistical analyses of the correlation of glucose levels among these sample types.
Daniel Brown, PhD, CCRC and Head of Clinical Affairs for GBS stated, “While a systematic literature review reveals numerous clinical investigations of salivary glucose levels, we at GBS believe that this is the first clinical study to utilize an independent, validated, traceable reference measurement to characterize glucose in oral fluids.”
He added, “We are privileged to collaborate with the Diabetes Research Institute and Johns Hopkins University to complete this important research and thank them in their support in this study. We look forward to continued statistical analysis of the data generated during this study.”
Key Points to Highlight:
- The clinical study followed an IRB-approved protocol.
- 40 adult subjects with type 2 diabetes were recruited for the study. The subjects represented a distribution of gender and age.
- Nearly 1400 samples of blood and oral fluids were collected and analyzed.
- GBS used independent glucose measurement procedures to quantitate glucose in oral fluids and blood, in order to characterize the degree of agreement among the various sample types.
- GBS engaged with Johns Hopkins University to develop and validate a primary reference method for the measurement of glucose in saliva.
- Analysis of the resulting data will explore the degree of agreement among glucose levels in oral fluid and blood samples by subject and across the entire cohort.
- The Company will provide further details on the analysis in its upcoming earnings press release and on the quarterly conference call.
The data generated from this study will become the foundation for building a robust portfolio of prospective clinical evidence, forming the backbone for future regulatory submissions. There is a shortage of studies of salivary glucose that use independent, validated means of analyzing glucose levels in saliva. The Company anticipates further clinical studies in the fourth quarter of this year and will utilize Saliva Glucose Biosensors fabricated at the Centre for Organic Electronics in New South Wales, Australia.
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