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.
This project sought to provide a novel approach for early detection of oral cancer. Oral cancer is a disease that strikes about 35,000 people in the United States each year. Because it is often detected in late stages when it is difficult to treat a majority of patients die from the disease. This project worked to test and optimize a noninvasive method to detect oral cancer so it would be caught early when it is curable. The ultimate goal is a product with a small brush to collect the oral sample and an instrument in which the brush head is placed which outputs a report on the presence of oral cancer within hours. The Phase I feasibility study focused on demonstrating that an RNA-based noninvasive diagnostic can be used as a reliable method to detect oral cancer. In our earlier work we showed that cells taken from oral tumors with a small brush provide RNA from the cells. These RNAs can be measured, and based on the level of several RNAs one can identity the cells as malignant. We started this study with a 5 RNA based classifier for oral cancer that needed testing and optimization. In this latest part of the project we have identified several different types of RNA that are additional markers of oral cancer. These markers are measurable even in brush samples taken under nonideal conditions a problem with our first generation oral cnacer classifier.. This brings us closer to having a product that will allow dentists and support people and other clinicians to test any type of blemish or sore in the mouth to determine if it is malignant - all without taking a surgical biopsy and without requiring a referral to a specialist.
