Low-cost, point-of-care tools for saliva diagnostics of salivary gland disorders represent an unmet need in medicine. Current research and clinical testing in this area often rely upon large, expensive analytical equipment with lengthy turnaround times. This time adds to the time needed to cryogenically preserve saliva for transport to an off-site laboratory. Giner proposes to develop a compact, cost-effective electrochemical sensor for point-of-care diagnosis and treatment of oral diseases such as Sjgren's Syndrome. A low-cost device will enable more widely available units for a range of clinical settings with reduced sample handling and transport time. The approach uses a cost-effective, label-free bio-FET (Field Effect Transistor) sensor utilizing high-specificity aptamers for recognition and capture of salivary biomarkers to be used in all dental offices for early detection of severe oral conditions and diseases such as Sjgren's Syndrome (SS). The Phase I feasibility study will demonstrate detection of carbonic anhydrase I (CA1), a recently reported salivary biomarker for Sjgren's Syndrome (SS). Combined with a microfluidic platform, multiple biomarkers can be measured for increased diagnostic certainty while the use of diagnostic biomarkers in saliva greatly reduces patient stress, especially in children. The proof of concept will be based on the demonstration of low detection limit, response stability, linearity and rapid turnaround. Device readings will be validated using conventional ELISA. The Phase II microfluidics platform will be compact, portable and designed for easy operation in dental clinics with small saliva specimens. The design will permit expansion to include multiple biomarkers determined from single specimens of saliva. The sensor will also be suitable for exploratory research into new, promising biomarkers for which replaceable sensors can easily be fabricated and calibrated as required.

Public Health Relevance

Low-cost, point-of-care tools for non-invasive saliva diagnostics of salivary gland disorders represent an unmet need in public health. Giner, Inc. will develop a compact, cost-effective bio-FET label-free sensor with a microfluidics platform for detection of one or more diagnostic biomarkers to aid in the treatment of oral diseases and to develop a better understanding of the physiology and pathophysiology of damaged glands. The concept will be demonstrated using a known protein in saliva associated with Sjgren's Disorder to show detection limits, range, analysis time, and response linearity.

National Institute of Health (NIH)
National Institute of Dental & Craniofacial Research (NIDCR)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1)
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Chander, Preethi
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Giner, Inc.
United States
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