Clinical Trial Acceleration through Risk Stratification

Predict Cardiovascular Events with the SomaLogic CVD 2º Risk Panel

If you could accurately predict the risk of a cardiovascular event at baseline, how would that information impact the design and execution of your trial?

  • Validated for patients with stable coronary heart disease
  • Enroll patients with high risk into efficacy trials.
  • Disqualify patients who are not likely to have an event.
  • Reduce the number of patients enrolled.
  • Accelerate time to endpoint.
Biomarker Discovery to Clinical Diagnostic Panel1
  • The SOMAscan® 1.1k Assay was used for hypothesis-free biomarker discovery
    • 1,129 proteins measured simultaneously in 150 microliters of EDTA plasma
  • 1,909 samples with outcomes and clinical metadata analyzed to build and validate the algorithm1
  • Machine learning was used to select biomarkers to predict myocardial infarction, congestive heart failure, stroke/transient ischemic attack or death.
  • A multi-protein panel assay was developed.
Accelerate Time to Endpoint2
  • Assumptions in the financial model
  • Enrichment with 5-year CVD Risk Score >40%
  • Includes increased cost for risk screening
    • 20% of potential subjects are enrolled
  • Endpoint for the enriched trial is defined by the # Events in the All Comers design

Notify Me

We will alert you when the SomaLogic CVD 2o Risk Panel is available.

Start Here

Download the SomaLogic CVD 2º Risk Panel Flyer for Drug Developers.
Download the JAMA Data Summary Flyer

1- Ganz P et al. (2016). Development and Validation of a Protein-Based Risk Score for Cardiovascular Outcomes Among Patients with Stable Coronary Disease. Journal of the American Medical Association. Doi:10.1001/jama.2016.5951
2- 
Examination of Clinical Trial Costs and Barriers for Drug Development, HHS, July 2014