High Throughput Method for Cancer related HPV subtyping

HPV感染可能会导致宫颈癌。在世界范围内，宫颈癌是女性中第二常见的癌症。在美国，每年约有13,000例新病例和4,500例死亡病例。虽然巴氏试验可以识别宫颈癌的可能性，但更直接的HPV(人乳头瘤病毒)分子检测将受到欢迎。 我们开发了一种专有的基因阵列技术，用于高通量突变检测。这项名为ROCASH的技术用于报告特定杂交后的寡核苷酸捕获(正在申请专利)，是一种敏感、特异、可重复和负担得起的检测病原体核苷酸的方法。我们的技术平台将选择Luminex公司开发的xMAP技术。XMAP技术使用颜色编码的珠子来提供探针的特异性，并通过激光检测和实时数据记录来区分杂交信号。我们建议使用ROCASH技术来识别13个高危HPV亚型。 在此Fast Track应用程序的第一阶段，我们将完成分析验证。具体目标包括：设计和实施质量控制措施；建立分析灵敏度；建立分析特异性；以及提高分析的稳健性。 该方法为核苷酸检测提供了一种新的方法。ROCASH方法提高了灵敏度和特异度，可用于任何高通量平台(如xMAP)。 为了确保商业上的成功，我们在研发和营销方面建立了强大的合作网络。在美国，我们有Quest诊断公司和约翰宁博士帮助我们进行研发，在中国，我们有复旦张江愿意投资300万美元来营销开发的产品。

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 include: 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.