STTR Phase I: A noninvasive gene expression based classifier for oral cancer

This Small Business Technology Transfer Research (STTR) Phase I project will focus on oral cancer (OC), a disease that strikes over 30,000 new patients each year in the US resulting in about 8,000 deaths and even more disfigurements. This costs hundreds of millions of dollars in medical fees. A surgical biopsy with histopathology diagnosis is routine for oral tumor assessment and about one million oral biopsies are done each year in the US. Currently a dentist will detect a discoloration or spot in the patient?s mouth and advise the patient to see an oral surgeon to have the lesion surgically biopsied if it remains 2 weeks later. However, many patients wish to avoid the biopsy, choose to ignore the lesion, and if it is early cancer it goes undetected. There is a clear need for a noninvasive method to detect early OC. The study proposes to use a small brush to obtain cells from oral discolorations that may be early cancers and then analyze the RNA. If done properly this analysis may allow the detection of a developing cancer This provides a means to detect oral cancer early when it can be cured, that does not rely on a surgical biopsy. The broader impact/commercial potential of this project is to make the detection and diagnosis of early oral cancer one-step, noninvasive, and accurate. This would make the detection of this cancer easier, increase the percentage of oral cancers that are detected early and result in improved cure rates. These patient are treated just with surgery require no chemotherapy or radiation and usually do very well. The goal of this project is create the first non-invasive oral cancer cell based detection kits involving RNA or DNA analysis to be used in the clinic. The technology, gene expression based classification, could be adapted to diagnose other oral diseases often misdiagnosed and inaccurately linked to oral cancer such as lichen planus, papilloma, severe gingivitis, etc.