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. DiaCartas RadTox QuantiDNATMdiagnostic product measures tissue loss and is related to RADIATION dose, field size, known sensitive organ exposure, and use of sensitizers. RadTox QuantiDNATM is a unique, first generation, patented technology that measures acute tissue damage shortly (24 hr) following a first RADIATION exposure. RadTox QuantiDNATM employs a few microliters of Plasma from blood. Moreover, as DiaCarta already has CLIA-ready and CE-marked products on the same platform, regulatory approval would be sought and easily achieved. In this phase I SBIR, DiaCarta proposes to: Objective 1: Develop a CLIA certification-ready test for immediate deployment in clinical studies using our CLIA certified laboratory Objective 2: Evaluate RadTox QuantiDNATM using prospective toxicity data and parallel Plasma specimens from prostate cancer patients Assuming positive pilot data we will prepare and submit a Phase II SBIR to conduct a pivotal clinical study and develop additional organ-specific products using RadTox QuantiDNATM.
NIH Spending Category: Cancer; Clinical Research; Clinical Trials and Supportive Activities; Patient Safety; Precision Medicine; Prostate Cancer; RADIATION Oncology; Urologic Diseases
Project Terms: Acute; ADVERSE REACTIONS; Apoptosis; base; Biological Markers; Cancer Patient; Cell Death; Certification; CLIA certified; Clinical Research; Clinical Trials; Code; Data; Data Analyses; design; Detection; Development; DNA; Dose; Generations; Human Papillomavirus; Individual; Institutional Review Boards; Laboratories; Legal patent; Malignant neoplasm of prostate; Measures; meetings; Necrosis; Organ; Patients; Phase; Pilot Projects; Plasma; PREDICTIVE marker; Process; Production; prospective; Protocols documentation; Protons; RADIATION; RADIATION Injuries; RADIATION therapy; RADIATION Toxicity; Small Business Innovation Research Grant; Source; Specimen; Technology; Testing; Tissues; Toxic effect; trial design; Validation
