Saliva, like blood, contains a wealth of hormones, proteins and nucleic acid molecules that reflect physiological status;however, unlike other bodily fluids such as blood, salivary diagnostics offer an easy, inexpensive, safe, and non-invasive approach for biomarker identification, disease detection and drug monitoring, and have a high potential to revolutionize the next generation of clinical diagnostics. A major drawback to the use of saliva for these applications, however, is the requirement for cold chain management, which involves the transportation samples through refrigerated packaging methods and safeguards to protect the integrity of collected samples. Specifically, the central issues for salivary diagnostics are that: (1) maintaining the cold chain can be cost prohibitive for large scale surveys;(2) maintaining the cold chain is not possible in many global health applications;(3) not properly managing the cold chain significantly compromises sample integrity and assay precision;and (4) many patients and research participants employing at-home sample collections are not capable of executing complicated standard operating procedures for cold chain management. Hence, alternatives to cold chain management are essential in order to expand the saliva bioscience market and to enhance the value and utility of saliva biorespositories. Salimetrics has pioneered salivary bioscience by focusing its business strategy on standardizing immunoassay protocols specifically for use with oral fluid samples, and more recently standardizing saliva collection techniques and procedures. Salimetrics sees a commercial opportunity to standardized and improve upon how samples are treated after they are donated and before they arrive at the lab bench for assay. How samples are handled, transported, and stored has a dramatic influence on the value of the information derived from those specimens. In this application, we propose to develop and optimize collection, stabilization and processing of saliva analytes at ambient/room temperature (~22 C). Specifically, stabilizers that control oxidation, peptidases, and pH, as well as bacteria and other oral contaminants will be tested to assess analyte stability and consistency for hormone and protein measurements in saliva. The development of ambient temperature stabilization protocols for salivary analytes will dramatically advance saliva-based diagnostics. These advances will facilitate the development of at-home sample collection kits, increase access to previously underserved populations and significantly reduce the costs of saliva sampling and analysis.

Public Health Relevance

Saliva, like blood, contains a wealth of hormones, proteins and nucleic acid molecules that reflect physiological status;however, unlike other bodily fluids, salivary diagnostics offer an easy, inexpensive, safe, and non-invasive approach for disease detection, and possess a high potential to revolutionize the next generation of diagnostics. The development of ambient temperature stabilization protocols for salivary analytes will dramatically advance saliva-based diagnostics, which will facilitate the development of at-home sample collection kits, increase access to previously underserved populations and significantly reduce the costs of saliva sampling and analysis.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DE024026-01
Application #
8648107
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Melillo, Amanda A
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Salimetrics, LLC
Department
Type
DUNS #
City
State College
State
PA
Country
United States
Zip Code
16803