Immunoassays for quantifying a newly verified oral cancer biomarker “OCBM-1” in saliva specimens. Including two platforms: ELISA Kit and colloidal-gold based strip assay, which provides quantitative and semi-quantitative amounts of OCBM-1, respectively. Now the two products are at pilot production stage, which will be soon applied for pre-clinical verification and clinical 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, and no OCBM-1-related IVD or international standard in the world. All the materials in the immunoassay are developed and produced by ourselves in Taiwan.

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