Carrera Bioscience Inc. — Department of Health and Human Services SBIR Phase II: ODCDC

Description

There is a pressing need to detect and differentiate all forms of viral hepatitis in patient samples as a point of care assay The existing FDA cleared PCR based HBV and HCV diagnosis kits require sophisticated instrument and sample processing which is not applicable for field use Carrera Bioscience proposes to build upon their Phase I work to develop assays for all five hepatitis viruses using loop mediated isothermal amplification LAMP of viral nucleic acids All five viruses will be assayed simultaneously in non powered environments using the handheld Diagenetix Bioranger instrument for real time fluorescent detection A no power sample prep will be developed for the assay and the entire process can be completed in about one hour Clinical tests will be performed with characterized samples of multiple genotypes to determine the sensitivity and specificity in preparation for FDA k regulatory application The development of these hepatitis assays aims to reduce the number of people who die from hepatitis related causes each year which currently stands at approximately million The platform will be applicable for point of care rapid diagnosis of not only hepatitis but other infectious diseases which would be useful for global disease surveillance clinic testing and blood and organ donor screening