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Accelerated Medical Diagnostics, Llc | Entity website

At the Sept. 21 Fall Convocation, Paul Henderson, CEO, and UC Davis adjunct faculty of Hematology and Oncology in the School of Medicine, speaks to the gathered assembly of faculty, staff, students and community members about his research into which technologies will benefit ...


Accelerated Medical Diagnostics, Llc | Entity website

NIH/NCI SBIR Phase I SBIRContract HHSN261201200048C (Paul Henderson,PI) Active: 09/28/10-6/30/12 Phase 0 Microdosing Diagnostics Clinical Trial The goal of this project is to determine the cut point in microdose-induced carboplatin-DNA adducts that stratifies responders from nonresponders. $200K NIH/NCI SBIR Phase II SBIR Contract HHSN261201200048C (Paul Henderson,PI) Active: 09/28/12-9/27/14 Phase 0 Microdosing Diagnostics Clinical Trial The goal of this project is to determine the cut point in microdose-inducedcarboplatin-DNA adducts that stratifies responders from nonresponders ...


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2012

We developed a technology called PlatinDx that, based upon preclinical data, can potentially identify chemoresistance in lung and bladder cancer patients before they receive carboplatin therapy. PlatinDx utilizes tracing of subtherapeutic microdoses of14C-labeled carboplatin with accelerator mass spectrometry (AMS), which has attomole (10-18 mole) sensitivity for 14C. We hypothesize that DNA damage caused by a single subtoxic microdose of carboplatin can predict patient outcomes such as tumor shrinkage, progression free survival and toxicity. The goal of the project is to test the clinical feasibility of PlatinDx in bladder and lung cancer patients. The PlatinDx data will be compared to ERCC1 expression using the Response Genetics RT-PCR assay as a benchmark. The resulting feasibility data will allow the design of a Pivotal Trial, which is required for FDA clearance and product launch.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 199.97K | Year: 2012

A. Background Information We developed a technology called PlatinDx that, based upon preclinical data, can potentially identify chemoresistance in breast cancer patients before they receive oxaliplatin therapy. PlatinDx utilizes tracing of subtherapeuticmicrodoses of 14C-labeled oxaliplatin with accelerator mass spectrometry (AMS), which has attomole (10-18 mole) sensitivity for 14C. We hypothesize that DNA damage caused by a single subtoxic microdose of oxaliplatin can predict patient outcomes suchas tumor shrinkage and survival. The goal of the project is to define the appropriate chemical (~1/100th the therapeutic dose) and radiochemical dose (a chest x-ray exposure) for the microdose composition, to establish protocols for the procedure and to gather preliminary clinical data. Breast cancer patients will receive a 14C-oxaliplatin microdose a few hours prior to normal biopsy. DNA will be isolated from white blood cells and left over tumor biopsy tissue. Drug-DNA damage levels will be measured by AMS and compared to outcomes such as tumor shrinkage, recurrence and severity of side effects. The data will be compared to ERCC1 expression and other biomarkers using the Response Genetics RT-PCR assay as a benchmark. The resulting feasibility data will allow the design of an SBIR Phase II diagnostics study. B. Phase I Technical Objectives The proposed Phase I clinical study will determine the feasibility of using [14C]oxaliplatin combined with AMS for clinical diagnostics trials using breast cancer patients. A clinical study is proposed due to substantial preclinical data (presented below). C. All patient recruitment for this SBIR Phase I study will be conducted by UC Davis. D. Experiments using accelerator mass spectrometry (AMS) will be performed by Accelerated Medical Diagnostics staff at the Lawrence Livermore National Laboratory.


Accelerated Medical Diagnostics, Llc | Entity website

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