Clinical mass spectrometry test for apolipoprotein C-III proteoforms

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43GM128459-01
Agency Tracking Number: R43GM128459
Amount: $153,545.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA17-302
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-05
Award End Date (Contract End Date): 2019-02-28
Small Business Information
9305 S STANLEY PL, Tempe, AZ, 85284-3356
DUNS: 080693616
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 DOBRIN NEDELKOV
 (602) 295-4874
 dobrin.nedelkov@isoformix.com
Business Contact
 DOBRIN NEDELKOV
Phone: (602) 295-4874
Email: dobrin.nedelkov@isoformix.com
Research Institution
N/A
Abstract
PROJECT SUMMARY Only about dozen mass spectrometryMSprotein tests have been translated into clinical laboratories since the MALDI and ESI approaches were developed thirty years agoWhile the cost and complexity of these tests are important factors impeding their clinical adoptionnew content generated via proteoforms detection could provide the impetus for further development and translationOur recent studies have revealed strong associations between relative abundance of a specific apolipoprotein C III proteoforms and plasma triglycerides concentrations in multiple cross sectional and longitudinal cohortsand also suggested prognostic and possible mechanistic role in dyslipidemia and cardiovascular disease riskThese intriguing results warrant further large scale investigations to verify the biomarker potential of these proteoforms in lipid metabolism and cardiometabolic riskWe propose to develop and demonstrate a low costhigh throughput MALDI TOF MS apoC III proteoforms test that will find immediate use in clinical utility studies of these proteoformsThe test workflow will include immunoaffinity isolaton of apoC III from minimal amounts of human plasma with antibody coatedwell platesand elution onto MALDI targets for MS analyses and determination of the proteforms relative abundanceThe steps of antibody immobilizationsample dilutionassayingrinsesand elution onto MALDI targets will be optimizedThe number of assay steps will be kept to a minimumto keep the cost per test lowReproducibility of the new test will also be evaluatedThe proposed MS test is innovative in its simplicitycostand content deliveredit will transform clinical research and diagnostics by enabling fast and cost effective screening of apoC III proteoformsSimilar tests for other proteins can also be developedsignificantly expanding our ability to study human proteoforms and their role in disease diagnosistherapy monitoringand outcome PROJECT NARRATIVE The new apolipoprotein C III MS test will transform clinical research by enabling fast and cost effective screening of apoC III proteoformsThe new test could find rapid use in extensive clinical studies of the proteoforms that will expand our understanding of apoC pathophysiology and its impact in lipid metabolism and cardiometabolic risk

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

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government