MEDIOMICS, LLC — Department of Health and Human Services SBIR Phase II: Early diagnosis of the hepatitis C virus (HCV) infection is crucial for treatment and prev
MEDIOMICS, LLC — SBIR Phase II award from Department of Health and Human Services.
- Amount
- $737,952
- Agency
- Department of Health and Human Services · Centers for Disease Control and Prevention
- Program / Phase
- SBIR · Phase II
- NAICS
- —
- Place of performance
- MO
- Period
- —
Description
Early diagnosis of the hepatitis C virus (HCV) infection is crucial for treatment and prevention. PCR screening and ELISA-based assay are currently used to detect viral RNA and HCV antibodies in patient blood samples. There are, however, no commercially available serological assays which can discriminate between acute and chronic HCV infection. In the phase I project, the company developed magnetic bead-based PINCER assay as well as homogeneous PINCER assays for quick detection of anti-HCV IgG and IgM. To continue this project, it is proposed to 1. Validate the magnetic beads-based PINCER assay with patient samples, 2. Develop homogeneous PINCER assays using a complete panel of HCV antigens and validate the assays with clinical samples and 3. Develop and validate PINCER assays for HCV core antigen. It is expected that after successfully implementing the phase II project, the company will provide a unique set of simple, robust and cost-effective screening tools for detection of anti-HCV antibody and antigens for diagnosis of acute and chronic HCV infection