Clinical study predicting risk of near-term MI and death in CAD patients to be published in JACC

May 9 2013

FirstMark, a division of GenWay Biotech that is focused on developing and commercializing noninvasive diagnostic and health monitoring tests for unmet clinical needs, today announced that results from the break-through proof-of-concept clinical study, performed in collaboration with Emory University and MedStar Washington Hospital Center, will be published in the Journal of the American College of Cardiology. The peer-reviewed article entitled "Aggregate Risk Score Based on Markers of Inflammation, Cell Stress, and Coagulation is an Independent Predictor of Adverse Cardiovascular Outcomes" will publish this week online and in the July 23, 201, printed edition of the Journal of the American College of Cardiology.

Thomas Silberg , President and CEO of GenWay Biotech stated, "We are extremely proud to have these results, demonstrating the power of FirstMark's innovative aggregate biomarker strategy to risk-stratify patients with coronary artery disease, published in the prestigious Journal of the American College of Cardiology. The acceptance of the peer-review article demonstrates confidence in the sound science behind the study. It is a tremendous recognition and we look forward to the interest that this article will generate for the ground-breaking FirstMark technology."

The clinical study demonstrated the extraordinary effectiveness of the test to predict risk of near-term (2-3 years) myocardial infarction (MI) and death in patients with suspected or confirmed coronary artery disease (CAD). The study revealed superior cardiac risk information by identifying the top 4% of CAD patients at the highest risk of MI or death with a hazard ratio of 5 compared to the 34% at lowest risk. The data showed an annual MI or death rate of 18.2% in patients with significant CAD who had all three biomarkers elevated compared to a 2.5% annual risk in those with normal biomarkers. The multiple biomarker model adds markedly to traditional risk prediction by significantly improving the C-statistic from 0.72 for base model to 0.75, and net reclassifying 42% of subjects.

"These results are quite astounding…The ability to identify both high and low risk individuals—and with the high risk group having an annual risk of MI or death of 18%--will undoubtedly have a major impact on physician decision-making, providing key information so that physicians can devise a rational strategy for further diagnostic testing and individualized patient therapy," stated Dr. Stephen E. Epstein , Director, Translational and Vascular Biology Research, MedStar Heart Institute, MedStar Health Research Institute, MedStar Washington Hospital Center.

SOURCE FirstMark