Development of Rapid Immunological Test for Oral Cancer Salivary Biomarker OCBM1 (I)

Oral cancer, one of the malignant diseases with high prevalence in Taiwan, has become a growing burden of our health care system. Currently, visual screening of oral mucosa of high‐risk subjects combined with pathological examination of tissue biopsy is the most common strategy for early detection of oral cancer in the endemic areas including Taiwan. However, according to data from our government’s Oral Cancer Screening Program, the detection rate of early‐stage oral cancer has not been significantly improved by using this strategy in the past 5 years. Although many candidate biomarkers for oral cancer have been discovered in the past decades, however, very few of them have been verified and translated into clinical use. Importantly, there are no any biomarkers currently approved by official health agents in the endemic areas for aiding OSCC management. We previously applied the multiplexed LC‐MRM‐MS (liquid chromatography‐multiple‐reaction monitoring‐mass spectrometry) technology to successfully verify a salivary protein, tentatively designed as OCBM1, as the best candidate biomarker through the simultaneous quantification and comparison of dozens of prioritized candidate biomarkers in hundreds of saliva specimens collected from different subject groups enrolled in the nationwide Oral Cancer Screening Program. OCBM1 is a kind of secretory protein with signal peptide. This nature together with our finding that its levels in saliva are drastically and significantly increased in a major part of oral cancer patients as compared with other non‐cancer subjects imply OCBM1 as an ideal target for development of rapid immunological test for detecting oral cancer using saliva samples. The goal of this project is to develop a sensitive immunological test (rapid immune colloidal gold strip assay) as an in vitro diagnosis device (IVD) prototype for detecting oral cancer based on the salivary levels of OCBM1. Recombinant proteins and high titer antibodies of OCBM1 will be produced to assemble a prototype of OCBM1 rapid test with reasonable sensitivity and high specificity. Several hundreds of saliva specimens with known OCBM1 levels and definite diagnosis previously collected from different subject groups enrolled in the nationwide Oral Cancer Screening Program will be used to evaluate the efficacy of this rapid test for oral cancer detection. We expect that the success of development of this OCBM1‐based rapid test can provide a new molecular tool to help first‐line health workers and specialists in both early detection and management of oral cancer.

Project ID:PC10406-0234
External Project ID:MOST104-2325-B182-003