KIRKLAND, Wash., Sept. 7, 2016 /PRNewswire/ -- Prevencio, Inc., a pioneer in multi-protein diagnostic and prognostic tests for cardiovascular disease and related adverse events, today announces the presentation of Late-Breaking Science at the European Society of Cardiology (ESC) Congress, the world's largest and most influential cardiology meeting. Prevencio researchers teamed to develop a clinical and multi-protein panel to diagnose obstructive coronary artery disease. The data was presented by Principal Investigator, James L. Januzzi, MD, a practicing cardiologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School.
Researchers assayed and analyzed blood proteins and clinical variables from the Catheter Sampled Blood Archive in Cardiovascular Disease (CASABLANCA Study). For this study, 927 subjects with coronary angiography were included, and considered for the presence or absence of >70% obstruction in at least one major coronary artery. The data demonstrated high accuracy for the score to predict the presence of significant coronary obstruction. The score had an area under the receiver operating characteristic curve (AUC) of 0.87, and had 90% positive predictive value (PPV) for a one cut-off score. In an alternative five score model, a score of 5 (very high risk) produced a PPV of 93% and a score of 1 (very low risk) produced a negative predictive value (NPV) of 91%.
When the new test score, referred to as HARTTM CAD, was compared with available data for the renowned Framingham Risk Score (FRS), the HART CAD produced consistent and superior performance for predicting presence of coronary artery disease (AUC of 0.87 for HART CAD versus 0.52 for FRS). Similarly, when HART CAD was compared with available data for exercise and nuclear stress tests, which are standards of care in the evaluation of coronary artery disease, the HART CAD was substantially more accurate for predicting coronary artery disease (AUC of 0.87 for HART CAD versus 0.52 for stress testing).
"We were pleased to identify a diagnostic score of clinical variables and proteins with excellent accuracy for the diagnosis and exclusion of patients with underlying significant coronary artery disease," said Januzzi. "It is impressive the panel performed well across multiple groups including those without prior known coronary artery disease, those presenting without acute myocardial infarct, and notably in women, who represent a diagnostic challenge."
Consistent with its ability to predict presence of significant CAD, the HART CAD panel also predicted risk of future myocardial infarction (also known as MI or heart attack) and, in subjects with an elevated score, there was a shorter time to MI as compared to subjects with a lower score.
The panel's clinical parameters included sex and history of percutaneous coronary intervention, as well as four proteins (adiponectin, apolipoprotein C-1 [Apo C-1], kidney injury molecule-1 [KIM-1], and midkine). "Taken together, the proteins in our score represent a unique pathophysiologic mix of abnormal glucose and fatty acid metabolism (adiponectin), hyperlipidemia (Apo C-1), renal dysfunction/injury (KIM-1) and vascular injury and plaque infiltration (midkine), and explains why the 'orthogonal' information provided by these proteins added independent value to the clinical variables. We look forward to testing the HART CAD score in patients with different pre-test probabilities and hopefully bringing a new, non-invasive test to the millions of patients who need improved diagnosis for coronary artery disease," said Januzzi.
Interest in coronary artery disease is driven largely by the fact that the disease is a major public health concern. It is a leading cause of death in the U.S., affecting nearly 20 percent of people ages 65 and older. Current coronary artery disease testing modalities, including stress testing and cardiac computed tomography (CT) have limitations, including variable accuracy, limitations in obese and female patients, and need for ionizing radiation with adjunctive imaging for stress testing, as well as ionizing radiation, limited availability, and high costs for cardiac CT. Moreover, up to 50% of patients are needlessly referred for invasive coronary catheterization, subjecting them to additional ionizing radiation and complications including death. As such, a non-invasive, low-cost, and safe test would be valuable and potentially result in reduction of morbidity, mortality, and healthcare costs.
"It is rewarding to work with dedicated researchers to identify a panel that may safely and noninvasively help cardiac patients while also reducing healthcare expenditures," said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. "We look forward to our next steps of platform partnering, finalizing the testing kit, and conducting our FDA pivotal trial. We are also very thankful for the support of our investors."
About Prevencio:Prevencio is a pioneer in multi-protein diagnostic and prognostic tests for cardiovascular disease and related adverse events. The Company's proprietary HART™ CAD Test is a first-in-class product. The worldwide market potential for the HART™ Test is ~ $2 billion in recurring annual revenue. For additional information, the Company's website is www.PrevencioMed.com. Prevencio—Preventing the Preventable.™
Prevencio Media Contact: Rhonda Rhyne, [email protected], (858) 204-4116
Forward-Looking (Safe Harbor) Statement:Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, size, potential, growth and penetration rates, the accuracy of which is necessarily subject to uncertainties and risks including the Company's sole dependence on HART technology and various uncertainties characteristic of development stage companies. The Company does not undertake to update the disclosures contained in this press release.
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Researchers assayed and analyzed blood proteins and clinical variables from the Catheter Sampled Blood Archive in Cardiovascular Disease (CASABLANCA Study). For this study, 927 subjects with coronary angiography were included, and considered for the presence or absence of >70% obstruction in at least one major coronary artery. The data demonstrated high accuracy for the score to predict the presence of significant coronary obstruction. The score had an area under the receiver operating characteristic curve (AUC) of 0.87, and had 90% positive predictive value (PPV) for a one cut-off score. In an alternative five score model, a score of 5 (very high risk) produced a PPV of 93% and a score of 1 (very low risk) produced a negative predictive value (NPV) of 91%.
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When the new test score, referred to as HARTTM CAD, was compared with available data for the renowned Framingham Risk Score (FRS), the HART CAD produced consistent and superior performance for predicting presence of coronary artery disease (AUC of 0.87 for HART CAD versus 0.52 for FRS). Similarly, when HART CAD was compared with available data for exercise and nuclear stress tests, which are standards of care in the evaluation of coronary artery disease, the HART CAD was substantially more accurate for predicting coronary artery disease (AUC of 0.87 for HART CAD versus 0.52 for stress testing).
"We were pleased to identify a diagnostic score of clinical variables and proteins with excellent accuracy for the diagnosis and exclusion of patients with underlying significant coronary artery disease," said Januzzi. "It is impressive the panel performed well across multiple groups including those without prior known coronary artery disease, those presenting without acute myocardial infarct, and notably in women, who represent a diagnostic challenge."
Consistent with its ability to predict presence of significant CAD, the HART CAD panel also predicted risk of future myocardial infarction (also known as MI or heart attack) and, in subjects with an elevated score, there was a shorter time to MI as compared to subjects with a lower score.
The panel's clinical parameters included sex and history of percutaneous coronary intervention, as well as four proteins (adiponectin, apolipoprotein C-1 [Apo C-1], kidney injury molecule-1 [KIM-1], and midkine). "Taken together, the proteins in our score represent a unique pathophysiologic mix of abnormal glucose and fatty acid metabolism (adiponectin), hyperlipidemia (Apo C-1), renal dysfunction/injury (KIM-1) and vascular injury and plaque infiltration (midkine), and explains why the 'orthogonal' information provided by these proteins added independent value to the clinical variables. We look forward to testing the HART CAD score in patients with different pre-test probabilities and hopefully bringing a new, non-invasive test to the millions of patients who need improved diagnosis for coronary artery disease," said Januzzi.
Interest in coronary artery disease is driven largely by the fact that the disease is a major public health concern. It is a leading cause of death in the U.S., affecting nearly 20 percent of people ages 65 and older. Current coronary artery disease testing modalities, including stress testing and cardiac computed tomography (CT) have limitations, including variable accuracy, limitations in obese and female patients, and need for ionizing radiation with adjunctive imaging for stress testing, as well as ionizing radiation, limited availability, and high costs for cardiac CT. Moreover, up to 50% of patients are needlessly referred for invasive coronary catheterization, subjecting them to additional ionizing radiation and complications including death. As such, a non-invasive, low-cost, and safe test would be valuable and potentially result in reduction of morbidity, mortality, and healthcare costs.
"It is rewarding to work with dedicated researchers to identify a panel that may safely and noninvasively help cardiac patients while also reducing healthcare expenditures," said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. "We look forward to our next steps of platform partnering, finalizing the testing kit, and conducting our FDA pivotal trial. We are also very thankful for the support of our investors."
About Prevencio:Prevencio is a pioneer in multi-protein diagnostic and prognostic tests for cardiovascular disease and related adverse events. The Company's proprietary HART™ CAD Test is a first-in-class product. The worldwide market potential for the HART™ Test is ~ $2 billion in recurring annual revenue. For additional information, the Company's website is www.PrevencioMed.com. Prevencio—Preventing the Preventable.™
Prevencio Media Contact: Rhonda Rhyne, [email protected], (858) 204-4116
Forward-Looking (Safe Harbor) Statement:Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, size, potential, growth and penetration rates, the accuracy of which is necessarily subject to uncertainties and risks including the Company's sole dependence on HART technology and various uncertainties characteristic of development stage companies. The Company does not undertake to update the disclosures contained in this press release.
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SOURCE Prevencio, Inc.
