Colorectal cancer (CRC) is the second most common cause of cancer death in the US causing more than 50,000 deaths each year. Unfortunately, African Americans (AAs) experience disproportionate incidence and mortality rates of CRC across all races in the US due to a complex interplay of economic, social, and cultural factors. AA's higher incidence, lower rates of screening and later stage of diagnosis make them 1.5 times more likely to die of CRC than their White counterparts. To improve screening participation, enable early detection and reduce the disparities in CRC mortality, Beacon Biomedical aims to provide community physicians with an easy, affordable (<$50) and accurate point-of-care assay as an alternative for their AA patients who routinely avoid colonoscopies or fecal testing. From a single drop of blood, this assay will allow them too rapidly (<10 min) identify which of these screening non-compliant patients have a higher likelihood of having undiagnosed colorectal neoplasia (CRC sensitivity>90%, specificity>90%) while they are still in their offices. With real time discussions of results and the need for follow-up care, positive test results can provide a powerful motivation for patients to see their gastroenterologist despite thei historical reluctance to do so. To accomplish this aim, Beacon Biomedical has entered into a public-private partnership with NCI- Frederick's Center for Cancer Research (CCR) and Howard University to translate CCR's basic research on Cripto-1 (CR-1) into a point of care CRC screening device. In this SBIR, work begins by verifying the technical, clinical and cultural feasibility of achieving this critical goal. Technically, the work centers on replicating a publishd study (Bianco, 2006) that demonstrated CR-1's significant upregulation in white colorectal cancer patients (mean 4.68 ng/ml) versus controls (mean 0.32 ng/ml) using a first of its kind competitive ELISA assay that quantifies total Cr-1 (bound and free) and later using a dot blot assay that severs as a POC prototype. Clinically, work includes expanding upon the 2006 results in a study of 100 plasma samples. To ensure the assay works on the intended use population, samples will be split evenly between cases and controls; male and female; AA and White, in the first study to ever examine CR-1 levels in an African American cohort or in subjects with advanced adenomas. Culturally, patient preference survey will be conducted to ensure that there is a high intent to comply if a simple POC assay were available to AA's who avoid colonoscopies or fecal testing. If successful, Beacon's devices have the potential to alter clinica practice, significantly increase screening compliance, and reduce CRC morality among African Americans.
Unfortunately, African Americans are nearly one and a half times more likely to die from colorectal cancer (CRC) than the rest of the US population due to their higher CRC incidence rate, lower compliance with existing screening tests, and later stage of detection. To improve screening compliance and reduce CRC mortality within this vulnerable population, Beacon Biomedical aims to create an easy, affordable and accurate blood based point of care CRC screening test option for African American patients who routinely avoid colonoscopies and fecal tests.
