IGF::OT::IGF OTHER FUNCTIONS PHASE I, TOPIC 309, LABEL-FREE MULTIVARIATE CANCER DIAGNOSIS

Significant progress has been made recently in developing multi-analyte prognostic cancer signatures based on gene expression profiling (GEP). However, current industry-standard RT-PCR platforms require substantial amounts of clinical samples, such as multiple FFPE tumor sections. These large sample requirements preclude less invasive biopsy sampling techniques, such as fine needle aspiration. In addition, few patients and/or signatures can be assayed simultaneously on standard RT-PCR platforms due to limited spatial and analytical capacity, thereby driving up assay cost. To meet these challenges, a new RT-PCR platform for measuring multi-analyte prognostic cancer signatures will be evaluated. Based on WaferGen s SmartChip technology, this platform willenable template requirements to be reduced by 1/16th of conventional amounts while dramatically increasing the number of patients and signatures that may be run simultaneously. This innovation will greatly reduce costs and make such prognostic assays moreaccessible to cancer patients. In phase I, the new approach will be evaluated utilizing AmberGen s 12-gene colorectal cancer prognostic signature, which achieved 95% sensitivity and 99% specificity to predict recurrence in a blinded study. A custom SmartChip will be designed to enable the CRC recurrence signature to be measured simultaneously for 48 patients, and is expected to achieve similar levels of accuracy.