Immunoassays for quantifying a newly verified oral cancer biomarker “OCBM-1” in saliva specimens. Including two platforms: ELISA Kitcolloidal-gold based strip assay, which provides quantitativesemi-quantitative amounts of OCBM-1, respectively. Now the two products are at pilot production stage, which will be soon applied for pre-clinical verificationclinical validation.

1.	No routine biomarker test for oral cancer applied in clinical setting currently. Therefore, application of OCBM-1 will be beneficial for early detection of oral cancer.
2.	OCBM-1 is a newly verified salivary biomarker,no OCBM-1-related IVDinternational standard in the world. All the materials in the immunoassay are developedproduced by ourselves in Taiwan.

ELISA Kitcolloidal-gold based strip assay are common immunoassay platforms for protein measurement in clinical test. In this case, materials including antibodies, standard proteins,reagents were generated SOPs for large-scale productionquality control were established. The pipeline could be applied for developing immunoassays for other candidate protein biomarkers.