Beacon Biomedical, LLC — Department of Health and Human Services SBIR Phase I: NIBIB

Description

DESCRIPTION provided by applicant Colorectal cancer CRC is the second most common cause of cancer death in the US causing more than 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 AAandapos s higher incidence lower rates of screening and later stage of diagnosis make them 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 andlt $ 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 andlt min identify which of these screening non compliant patients have a higher likelihood of having undiagnosed colorectal neoplasia CRC sensitivityandgt specificityandgt 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 Frederickandapos s Center for Cancer Research CCR and Howard University to translate CCRandapos s basic research on Cripto CR 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 that demonstrated CR andapos s significant upregulation in white colorectal cancer patients mean ng ml versus controls mean ng ml using a first of its kind competitive ELISA assay that quantifies total Cr bound and free and later using a dot blot assay that severs as a POC prototype Clinically work includes expanding upon the results in a study of 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 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 andquot intent to complyandquot if a simple POC assay were available to AAandapos s who avoid colonoscopies or fecal testing If successful Beaconandapos s devices have the potential to alter clinica practice significantly increase screening compliance and reduce CRC morality among African Americans PUBLIC HEALTH RELEVANCE 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