DXTERITY DIAGNOSTICS INCORPORATED — Department of Health and Human Services SBIR Phase II: NCI
DXTERITY DIAGNOSTICS INCORPORATED — SBIR Phase II award from Department of Health and Human Services.
- Amount
- $1,498,643
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- Topic
- NCI
- NAICS
- —
- Place of performance
- CA
- Period
- —
Description
In this Phase II project the goal is to continue development and validate the radiation toxicity RadTox diagnostic test We will also explore if gene expression in blood can be used to predict radiation sensitivity In our Phase I study gene expression based biomarkers were identified the DxDirect based assay was developed and the prototype predictor algorithm was developed In Phase II the sample size will be increased to at least patients confounders will be identified the gene expression assay will be further developed and validated and the locked assay will be transferred to DxTerity s CLIA CAP laboratory for initial commercialization We will also begin Quality System Regulation QSR compliant product development During this Phase II SBIR contract we will complete Phase and Phase of product development DxTerity s long term intention is to submit the assay for eventual FDA clearance with the intention of being a product line upgrade to DxTerity s REDI Dx High Throughput Biodosimetry assay