DiaCarta, Inc. — Department of Health and Human Services SBIR Phase I: NCI

Description

In different individuals exposed to radiation radiation will cause variable levels of rapid combined tissue death cell apoptosis and necrosis leading to toxicity This acute tissue loss correlates with radiation injury DiaCarta sRadTox QuantiDNATMdiagnostic product measures tissue loss and is related to radiation dose field size knownsensitive organ exposure and use of sensitizers RadTox QuantiDNATM is a unique first generation patentedtechnology that measures acute tissue damage shortly hr following a first radiation exposure RadToxQuantiDNATM employs a few microliters of plasma from blood Moreover as DiaCarta already has CLIA readyand CE marked products on the same platform regulatory approval would be sought and easily achieved In thisphase I SBIR DiaCarta proposes to Objective Develop a CLIA certification ready test for immediate deployment in clinical studies using our CLIAcertified laboratoryObjective Evaluate RadTox QuantiDNATM using prospective toxicity data and parallel plasma specimens fromprostate cancer patientsAssuming positive pilot data we will prepare and submit a Phase II SBIR to conduct a pivotal clinical study anddevelop additional organ specific products using RadTox QuantiDNATM