Hyperoxaluria, an imbalance in oxalate homeostasis, is associated with idiopathic kidney stone disease, cystic fibrosis, Crohn's disease, and vestibulitis (vulvodynia). Hyperoxaluria results from, or is exacerbated by, the absence of the gut bacterium, Oxalobacter formigenes. There is increasing demand for detecting O. formigenes in patients. We developed a rapid PCR-based diagnostic, the XEntr(Ix)[TM] Oxalobacter formigenes Monitor and licensed it to a clinical reference laboratory. It is too labor intensive to be cost-effective. We propose to develop a kit form which is compatible with other microbial diagnostic kits. Specifically, we will develop (1) a microtiter-plate assay utilizing an ELISA capture probe with colorimetric detection of the PCR-amplified product; (2) obtain analytical performance data on the kit; and (3) define the milestones and experimental approach for Phase II. A microtiter-plate system will facilitate automation. The kit will be evaluated for analytical sensitivity, specificity, precision, and reproducibility per the NCCLS Guidelines. In Phase II, design, vendors, and packaging will be refined, followed by testing in clinical laboratories. Following Phase II, we will have sufficient performance data to submit for FDA approval. Development of this kit simultaneously with Ox-Control[TM], our nutritional supplement, and IxC1-62/47, our prescription enzyme replacement therapy, will provide diagnosis and prevention for patients with oxalate-related conditions.
Hyperoxaluria is associated with a number of important diseases, including idiopathic kidney stone disease, cystic fibrosis, Crohn's disease and vestibulitis, affecting millions of people in the USA. Because of a direct correlation between hyperoxaluria in these diseases and the absence of the bacterium, Oxalobacter formigenes, from the intestines, there exists a need for development of a simplified and time-saving monitoring system to identify this bacterium in at-risk populations.
