Technology ID
TAB-4546

Immunoassay-derived Protein Biomarkers of Atherosclerotic Cardiovascular Disease Risk

E-Numbers
E-515-2013-0
Lead Inventor
Levy, Daniel (University of Chicago)
Co-Inventors
Larson, Martin (Boston University)
D'Agostino, Ralph (Boston University)
Applications
Research Materials
Diagnostics
Therapeutic Areas
Cardiology
Development Stages
Pre-clinical (in vivo)
Lead IC
NHLBI

This technology includes a combination of 6 protein biomarkers and clinical risk factors to be used as an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) that can improve the identification of individuals at high risk for atherosclerotic cardiovascular disease (ASCVD). Incorporation of novel protein biomarkers of ASCVD risk into risk assessment algorithms may improve their ability to identify individuals at high risk for ASCVD. We conducted an immunoassay profiling of 47 circulating plasma proteins in over 5,000 participants from the Framingham Heart Study (FHS) free of overt cardiovascular disease who were 40 years of age or older, and identified a panel of 6 immunoassay derived protein biomarkers that independently predicted the occurrence of new onset ASCVD above and beyond established risk factors. The IVDMIA invention described combines the values of multiple variables using an interpretation function to yield a single, patient-specific result, that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease.

Commercial Applications
This risk assessment algorithm can be used to better identify individuals at high risk for ASCVD in whom proven preventive strategies can be applied to delay or prevent the onset of clinical ASCVD.

Competitive Advantages
In improving upon current clinical risk factor based ASCVD risk prediction models, the protein biomarker-based strategy that culminates in an IVDMIA will overcome a major limitation of current ASCVD risk assessment methods:
  • Ability to identify many high-risk individuals early in the course of subclinical disease progression
  • These protein biomarkers can be measured reliably and reproducibly, non-invasively through blood
Licensing Contact:
Shmilovich, Michael
shmilovm@nih.gov