IGF::OT::IGF R&D- MEDICAL: BIOMEDICAL (BASIC RESEARCH)

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Effective cancer management depends on early diagnosis, accurate tumor staging, and consistent monitoring. However, many current diagnostic procedures are invasive, expensive and unpleasant. In multiple recent published studies, circulating cell-free DNA (cfDNA) concentration and integrity (fragmentation pattern) has shown promise as a highly sensitive and specific, minimally invasive blood biomarker for multiple cancer types. InnoGenomics has a proprietary process enabling the most commonly employed genetic targets for this application, high copy number retrotransposable elements of varying sizes, to be simultaneously assayed in a highly sensitive multiplex qPCR reaction, with the inclusion of an internal positive control to monitor the presence of PCR inhibitors potentially present in blood serum or plasma. This SBIR Phase I project will focus on developing and evaluating the feasibility of a retrotransposable element based multiplexed qPCR assay to robustly quantitate and distinguish cfDNA integrity and concentration in blood plasma and serum from colorectal cancer (CRC) patients and control subjects. Such an assay will provide an accurate, minimally-invasive, rapid, high-throughput, and cost-effective method with the potential to complement or replace existing procedures for CRC detection, diagnosis, prognosis, treatment monitoring and/or surveillance, thereby improving CRC patient outcomes.