IGF OT IGF CELL FREE CIRCULATING DBA BASED ASSAY DEVELOPMENT FOR LIVER CANCER SCREENING

The need to develop an effective method for hepatocellular carcinoma HCC diagnosis is urgent even with identification of cancer DNA biomarkers The low concentration and fragmentation of cfDNA presents a formidable challenge to the translation of DNA markers to clinic JBS Science Inc has developed innovative solutions to these challenges by development of sensitive short amplicon PCR assays suitable for cfDNA and use of urine as the source for cfDNA that provides a high volume JBS innovations are suitable for developing cfDNA based assays in general HCC is our first application We have developed the cfDNA based assays for three validated HCC markers TP CTNNB and TERT mutations The Phase I is to standardize assay parameters and specimen selection urine or plasma culminating in a standard operating procedure SOP with an analytic sensitivity of copies with a specificity of a linearity of logs and a co efficiency of variation reproducibility of and to demonstrate at least sensitivity for HCC In Phase II we will deliver a CLIA dertified cfDNA based test that can be finished in one day for HCC diagnosis so that more HCC can be detected early to improve prognosis