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Phase 0 carboplatin microdosing diagnostics trial

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96520
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
N43CO201000133
Solicitation Year:
N/A
Solicitation Topic Code:
NCI
Solicitation Number:
N/A
Small Business Information
ACCELERATED MEDICAL DIAGNOSTICS, LLC
2121 2ND ST, B-101 DAVIS, CA 95616-5472
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: Phase 0 carboplatin microdosing diagnostics trial
Agency: HHS
Contract: N43CO201000133
Award Amount: $195,550.00
 

Abstract:

We developed a technology called PlatinDx that, based upon preclinical data, can potentially identify chemoresistance in cancer patients before they receive carboplatin or cisplatin therapy. PlatinDx utilizes tracing of subtherapeutic "microdoses" of 14C-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 and survival . The goal of the project is to define the appropriate chemical (-1 /1 DOth the therapeutic dose) and  radiochemical (few percent of a chest x-ray exposure) microdose composition, to establish protocols for the procedure and to gather preliminary clinical data. Lung cancer patients will each receive a 14C-carboplatin 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 pivotal diagnostic study.

Principal Investigator:

Paul Henderson
(925) 570-1615
paul.henderson@ucdmc.ucdavis.edu
Small Business Information at Submission:

ACCELERATED MEDICAL DIAGNOSTICS, LLC
2121 2ND ST, B-101 DAVIS, CA 95616-5472

EIN/Tax ID: 461389984
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No