Clinical trial acceleration through risk stratification

Predict cardiovascular events with the SomaLogic CVD Secondary 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 algorithm
  • 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 five-year CVD Risk Score >40 percent
  • Includes increased cost for risk screening
    • 20 percent of potential subjects are enrolled
  • Endpoint for the enriched trial is defined by the number of Events in the All Comers design

Contact Me

Let’s start a conversation about the SomaLogic CVD Secondary Risk Panel.

Download the SomaLogic CVD Secondary Risk Panel Flyer for Trial Enrichment.
Download the AHA Poster on Translation from Biomarker Discovery with the SOMAscan Assay to a Targeted Panel.

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. 351(23): 2532-2541.
2- Examination of Clinical Trial Costs and Barriers for Drug Development, HHS, July 2014