HPV infection could cause cervical cancer. World wide, cervical cancer is the second most common cancer among women. In the US, it is responsible for approximately 13,000 new cases and 4,500 daths each year. While a Pap test can recognize the possibility of cervical cancer, a more direct HPV (Human Papillomavirus) molecular test would be welcomed. We have developed a proprietary gene array technology for high throughput mutation detection. The technology, named ROCASH, for reporte oligo capture after specific hybridizaiton (patent pending), is a sensitive, specific, repeatable, and affordable method for detecting pathogen nucleotides. The xMAP technology developed by Luminex Corporation will be selected as our technology platform. The xMAP technology uses color-coded beads to give probe specificity and to defferentiate the hybridization signal via laswer detection and real time data recording. We propose to use the ROCASH technology to identify 13 high-risk HPV subtypes. In Phase I of this Fast Track application, we will complete analytical validation.
The specific aims i nclude: design and implement quality control measures; Establish the analytical sensitivity; Establish the analytical specificity; and Improve assay robustness. The proposed method represent a novel approach to nucleotide detection. The ROCASH method increased the sensitivity as well as specificity and could be incorporated into any high throughput platform (such as xMAP). To ensure commercial success, we have established a strong collaboration network for R&D and marketing. In US, we have Quest Diagnositcs and Dr. Johanning help us with R&D, in China, we have FuDan ZhangJiang willing to invest $3 million US on marketing the developed products.
| Han, Jian; Swan, David C; Smith, Sharon J et al. (2006) Simultaneous amplification and identification of 25 human papillomavirus types with Templex technology. J Clin Microbiol 44:4157-62 |
