Igf::ot::igf Cell-free Circulating Dba-based Assay Development for Liver Cancer Screening

Period of Performance: 09/19/2016 - 03/18/2017

$274K

Phase 1 SBIR

Recipient Firm

JBS Science, Inc.
Doylestown, PA 18902
Principal Investigator

Abstract

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: (1) development of sensitive short-amplicon PCR assays, suitable for cfDNA, and (2) 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, TP53, CTNNB1, 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 10 copies with a specificity of 1:1000, a linearity of 4 logs, and a co-efficiency of variation (reproducibility) of 0.99-1.0, and to demonstrate at least 80% 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 30% more HCC can be detected early to improve prognosis.