U01 Administrative Supplement Award

Through the core U01 cooperative research program, salivary biomarkers for AMI have been revealed for the first time. While important, this accomplishment represents only the initial step that is required to develop and secure approval for these new saliva-based diagnostic tests. Likewise, with the completion of an important pilot study (see Clinical Chemistry, 2009) that led to this discovery of new salivary AMI biomarkers, it becomes essential now to complete broader clinical studies to validate these biomarkers in the context of the final application whereby chest pain patients arriving at the emergency room will be examined.

The NIDCR division of NIH has recently approved an administrative supplement fund to support the team’s efforts to validate the biomarkers discovered as well as the programmable bio-nano-chip technology that hosts the tests that can measure them at the point of care, as the next important step in the process. For this supplement program, the team will expand its clinical collaborators above and beyond oral medicine to include Dr. Christie Ballantyne’s group, one of the leading cardiology groups in the world based at Baylor College of Medicine at the Texas Medical Center. Here, in addition to the highly established Clinical Director, the Ballantyne group brings in the expertise of Dr. Biykem Bozkurt, Chief of Cardiology Section, Michael E. DeBakey VA Medical Center. Dr. Bozkurt will serve as the clinical lead for this biomarker validation study. The program will also benefit from Dr. Vijay Nambi, Assistant Professor and staff cardiologist at Ben Taub Hospital, the second clinical site involved in the study, and Dr. Salim Virani, Assistant Professor and Staff Cardiologist Michael E. DeBakey VA Hospital. The program will also receive guidance from the biostatistics expert, Dr. Leif Peterson, who now serves as an Associate Member the Methodist Hospital Research Institute in Houston.

Through the establishment of the collaboration with the Ballantyne group at BCM, we have thus secured a key resource that will allow for the clinical validation to occur in an efficient and timely manner. Here, a significant amount of time has been spent to organize this joint Ballantyne and McDevitt clinical study. The addition of a strong foundation in the area of cardiac heart disease patient management serves as a key step in further expansion of this program and represents a major milestone for NIDCR in its capacity to expand oral diagnostics into important systemic diseases.

Related Saliva Diagnostics Research Groups

The National Institute of Dental and Craniofacial Research (NIDCR) division of the National Institutes of Health (NIH) is supporting a number of important scientific program that target the technological advances required for the development of portable instrumentation suitable for important saliva diagnostic assays.

The "Development of Technologies for Saliva/Oral Fluid-based Diagnostics" program is sponsored by the NIDCR. The program manager, Dr. Lillian Shum, coordinates activities for four research groups summarized below:

Dr. John T. McDevitt (Rice University) and Dr. Eric V. Anslyn (University of Texas at Austin)

The University of Texas at Austin (UT) has developed a novel sensor array platform that is well suited for point of care diagnostics. This technology is based on a micromachined bead-based platform that is amenable to multi-analyte detection and quantitation. The UT research groups have teamed with saliva diagnostics experts from University of Kentucky for the collection and analysis of clinical samples.

Dr. Daniel Malamud from the University of Pennsylvania

Dr. Malamud's research involves the identification and characterization of anti-bacterial and anti-viral molecules, assay development utilizing oral fluid as non-invasive diagnostics.  This research team is involved in designing a point detection system for identification of bacterial and viral pathogens.

Dr. David Walt from Tufts University

Dr. Walt's Optical Sensing Arrays labs are using a bead-based fiber-optic-based detection platform to investigate salivary diagnostics in the context of end-stage renal disease, asthma, and opportunistic infections.

Dr. David Wong from UCLA

Dr. Wong's UCLA-based "Human Salivary Proteome Project" is a multi-institutional multidisciplinary research consortium between UCLA and USC which goal is to produce a complete catalogue of all salivary secretory proteins using state of the art, sensitive and high-throughput proteomic technologies.