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Topic 345: RadTox - Measuring Radiation Toxicity using Circulating DNA

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N91018C00036-0-0-0
Agency Tracking Number: N44CA180036
Amount: $1,999,984.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: N/A
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
2600 Hilltop Drive Building B
United States
DUNS: 080348948
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Aiguo Zhang
 (510) 878-6662
Business Contact
 Aiguo Zhang
Phone: (510) 878-6662
Research Institution

The QuantiDNA RadTox System is a unique, patented technology that measures tissue damage shortly following injury using cell-free DNA from a drop of blood. Premised on murine and primate studies showing circulating DNA is logarithmically increased with whole-body radiation dose, RadTox has the potential to overcome many of the species-specific challenges faced by biomarker panels. The phase I SBIR for RadTox included assay validation in DiaCarta's CLIAcertified laboratory and a clinical trial comparing RadTox to the current gold standard for toxicity prediction, the dose-volume histogram. Phase I results confirmed that peak RadTox levels occurred in the first week and that the integral dose, bladder dose, and average peak and day-2 RadTox levels were significantly correlated. The proposed clinical study, powered for personalized toxicity endpoints based on historical observations, is needed to determine if RadTox can outperform dosimetry for toxicity prediction. We expect, for the first time, to subcategorize patients into personalized risk groups. The phase II SBIR will include the following tasks: (1) manufacture RadTox assay kits under GMP; (2) design and implement a clinical utility trial; (3) manage multi-institutional clinical specimen collection, with expert project and contract administration.

* Information listed above is at the time of submission. *

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