FirstMark, the diagnostic division of GenWay Biotech, Inc., has released study results and the commercial launch of PREvent. FirstMark PREvent is the first multiple biomarker test that accurately predicts near term (approximately 2-3 years) risk of myocardial infarction (MI) for suspected or confirmed coronary artery disease (CAD) patients.
FirstMark PREvent was launched, and the data from the phase I prospective study entitled, “Aggregate Risk Score Based on Markers of Inflammation, Immunity, and Thrombosis is an Independent Predictor of Adverse Cardiovascular Outcomes,” was presented by Danny J Eapen, MD, at the American Heart Association Scientific Sessions 2011 (AHA), in Orlando, Florida.
PREvent is a simple blood test based on technology developed and patented by GenWay, Emory University and MedStar. The test aggregates three biomarkers that identify the multiple pathways that lead to vulnerable plaques. The development and validation studies for the test were comprised of approximately 3,000 individuals with suspected or confirmed CAD. The studies showed PREvent to be significantly more powerful than other tests and risk factors, by identifying the top 10 per cent of confirmed CAD patients that are at a 6.45 times higher risk of a near term MI within a 2-3 year period, as compared to other CAD patients. The test also proved to be 12 times more powerful than the single biomarker CRP. In addition, 18 per cent of CAD patients with all three biomarkers elevated had a major event within the first year, compared to only 2% of CAD patients with normal biomarker levels.
PREvent is a critical advancement in cardiovascular medicine addressing the unmet need to access risk of near term MI. “This simple blood test is an exciting development for suspected or confirmed CAD patients, allowing physician's diagnostic clarity in identifying CAD patients that are in most urgent need of aggressive treatment and monitoring,” said Thomas Silberg, president and CEO of GenWay Biotech. FirstMark PREvent is now available and will be targeted to primary care physicians and cardiologists.
GenWay Biotech, is comprised of three divisions. The FirstMark division is focused on the development and commercialization of non-invasive diagnostic and health monitoring tests for unmet clinical needs.