Development and Feasibility of PerioDX for Identification of Periodontal Disease

Innovative Diagnostics, Inc., Lexington KY

Investigators

Abstract

? DESCRIPTION (provided by applicant): Periodontitis is a chronic polymicrobial bacterial infection that leads to soft and hard tissue destruction and is the leading cause of tooth loss in adults. Periodontitis also is associated with sequelae of several important systemic diseases seen in the population. Although microbial and host biomarkers have both been identified as independent predictors of periodontal disease, combining these measures into a single POC device would greatly increase the specificity and sensitivity of a diagnostic tool. Due to the increasing prevalence and associated co-morbidities of periodontitis, the availability of screening and diagnostic technologies for the early detection of periodontitis initiation and progression would have both a profound impact on public health and have significant commercial potential. The goal of this project is to develop a programmable bio-nanochip diagnostic device technology that uses antibody-coated agarose beads and membrane-based technology in a multiplex format to detect periodontal disease by targeting both microbes and host response biomarkers. This translational research effort is the continuation of a 12-year collaboration of an expert and diverse research team to further develop a next-generation POC diagnostic device for periodontal disease. The goal is to produce a highly reliable, reproducible, accurate and sensitive tool for early detection, screening, and monitoring of periodontal disease that would enable enhanced decision-making regarding treatment. This study is being performed by Innovative Diagnostics Inc. (IDI) and researchers from the University of Kentucky (UK), McDevitt Laboratory (Rice University), and SensoDx (Houston, TX). In this Phase I effort, a biochip device (PerioDXTM) will be developed that uses next generation disposable cartridges to rapidly detect and quantitate Porphyromonas gingivalis and matrix metalloproteinase (MMP)-8 in saliva from patients who have health or periodontal disease. Successful completion of these studies will lead to a Phase II application that targets expansion of the biological targets including additional bacteria and host molecules contributory to periodontal disease. These biological targets will be selected with the commercialization goal of creating a device that can be used in various professional venues, as well as resource poor settings to improve oral health with respect to screening, diagnosing and monitoring periodontal disease infections and progression. The Phase I study has two Specific Aims: Aim 1: Adapt and optimize the SensoDx platform for simultaneous detection of a periodontal pathogen (P. gingivalis) and a host response biomarker (matrix metalloproteinase-8) in whole saliva Aim 2: Evaluate salivary samples using PerioDX(tm) to differentiate healthy and periodontitis subjects