Full Press Release Details
Inc. Announces Institutional Review Board Approval to Initiate Clinical Trial at Sutter Health Mills-Peninsula Medical Center
trial is single center, prospective study to collect coincident samples of oral fluid and blood to evaluate the time-course of glucose
is expected to enroll approximately 40 adult subjects diagnosed with type 2 diabetes
is seeking to support clinical validation of its Saliva Glucose Biosensor through
use of the initial data, anticipated later this summer
York, NY, March 31, 2022 - 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 it has obtained Institutional Review Board (IRB) approval to initiate subject enrollment at the Diabetes
Research Institute of Sutter Health's Mills-Peninsula Medical Center (MPMC) in San Mateo, California. The study design is intended
to support the clinical development of its next-generation Saliva Glucose Biosensor.
study, Specimen Collection Methodology to Support Subsequent Correlation Analyses of Glucose in Oral Fluids, Capillary, and Venous
Blood, is expected to begin enrolling patients in 2Q'22. GBS anticipates initial data will be submitted for publication in
are excited to initiate this clinical study on schedule, an admirable feat given how challenged health systems have been by the protracted
COVID-19 pandemic," said Dr. Steven Boyages, Interim Chief Executive Officer. To establish the most robust correlation data, GBS
was particularly selective when identifying a collection center to ensure the integrity and quality control of each sample and subject
would be collected and processed in the highest standards possible. We are delighted to be working with David C. Klonoff, M.D., Medical
Director of the Diabetes Research Institute at Mills-Peninsula Medical Center and our Principal Investigator for this study."
will be working with:
| Sutter Health, Mills-Peninsula Medical Center to enroll approximately 40 adult subjects diagnosed with type 2 diabetes in the study. Measures to ensure adequate distribution of age and sex will be taken. | ||
| Sutter Health, Mills-Peninsula Medical Center will also collect and freeze saliva and blood samples for subsequent analysis by other partners. | ||
| Quest Diagnostics and the Johns Hopkins Hospital, Department of Pathology, will perform tests on the samples to determine the amount of glucose in oral fluids, venous blood and capillary blood. | ||
| GBS will perform subsequent statistical analyses of the correlation of glucose levels among these sample types. Dr. Klonoff will review the results of this analysis. |
Inc. is a life sciences company developing non-invasive, real-time monitoring and diagnostic tests for patients and their primary health
practitioners. With the world-first Biosensor Platform, GBS is developing and launching diagnostic tests urgently needed to help people
living with diabetes.
more information, please visit GBS.inc or follow GBS Inc. on Twitter and LinkedIn.
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