PREvent For Healthcare Professionals

FirstMark PREvent Cardiovascular Multiple Biomarker Blood Test

FirstMark PREvent is the first and only multiple biomarker blood test on the market that predicts near term (2-3 years) risk of myocardial infarction or death in patients with suspected or confirmed, insignificant or significant stable CAD. PREvent aggregates three cardiovascular biomarkers that identify the pathways that lead to vulnerable plaque formation. Research has discovered that there are multiple pathways that lead to formation of vulnerable plaques. PREvent aggregates three cardiovascular biomarkers, hsCRP, HSP70 and FDP, that identify these pathways, and projects the propensity for an individual to develop vulnerable plaques.

Fulfills an Unmet Need in Cardiovascular Medicine

According to the National Heart, Lung, and Blood Institute, other tests are primarily used as a diagnostic marker to determine whether a symptomatic patient has suffered a cardiovascular event, or to evaluate risk following a cardiac event. In addition, chronic or fixed risk factors are best suited to predict long term rather than near term risk.¹ PREvent is a critical advancement in cardiovascular medicine addressing the unmet need to access risk of near term MI.

Current Risk Stratification Methods

• Calcium Score
• Imaging technique
• Currently the only AHA 2A recommended test for CAD risk stratification
• After 3 years of follow-up high risk patients have 3.5% event rate vs. 1% low risk
• Problem: calcification may mean stable plaque which will not rupture

   

• LP-PLA2 (PLAC)
• Vascular-specific inflammatory marker
• Hazard ratio: 1.04 – 1.19
• Problem: not predictive of an event

   

• CardioSCORE
• Biomarker panel
• HR 2.5 – 3.5 (depending on FRS score)
• Event rate for high risk classified patients 6% vs. 2.5% low-risk
• Problem: low predictive power

   

• Individual markers such as CRP
• Problem: not predictive of an event
• Problem: poor C-statistic, do not add to the model

Cardiac Risk information

FirstMark PREvent enhances the ability to predict near-term risk of myocardial infarction by utilizing multiple biomarkers of inflammation including FDP, hsCRP and HSP70. The FirstMark PREvent inflammatory biomarkers are correlated to prospective risk of cardiovascular complications. The relevant prognostic information obtained is associated with greatly heightened near-term risk and impacts and supports healthcare professionals decision-making with regard to ordering additional tests. When compared to other tests and traditional risk factors, the synergy of PREvent’s three cardiac markers including, and the algorithm behind the test reveals superior cardiac risk information

• Identifies the top 4% of CAD patients at the highest risk of MI with a hazard ratio of 5.

• 18.2% of significant CAD patients with all three biomarkers elevated had a major event within a year, compared to only 2.4% rate with all biomarkers normal

• The multiple biomarker model adds markedly to traditional risk-prediction by significantly improving C-statistics from the base model of 0.695, up to 0.750 distinguishing high risk from low risk subjects