tANN ARBOR, Mich., Oct. 31, 2011 /PRNewswire/ — Everist Genomics, a rapidly growing personalized medicine company developing and commercializing innovative diagnostics and prognostics, announced today that it has successfully completed acquisition of 100% of the shares of Angiologix, Inc., the developer of the AngioDefender™ diagnostic device for assessing endothelial function. Endothelial cell dysfunction is a key biomarker of early-stage atherosclerosis and CVD; it is also the earliest detectable sign of atherosclerosis. (1)
tAngioDefender is a highly accurate and low-cost tool designed to allow physicians to assess endothelial function — a key indicator of blood vessel health. Clinical syndromes such as stable and unstable angina, acute myocardial infarction, claudication, and stroke relate, in part, to a loss of endothelial control of vascular tone, thrombosis, and the composition of the vascular wall. (2) Such a tool could aid in the diagnosis of early stage atherosclerosis and cardiovascular disease (CVD) in asymptomatic patients. Clinical studies (3) show that pharmacological and life style interventions are effective in treating endothelial dysfunction; these interventions are also efficacious in treating CVD:
tThe endothelium, a thin layer of cells that line the walls of every blood vessel, is essential to ensuring that blood flows properly throughout the body. Over time, the effects of high blood pressure, cholesterol, stress, alcohol, smoking and genetics can damage endothelial cells, preventing them from performing their vital functions. Eventually, this damage to the endothelial cells will result in accumulation of fatty deposits called plaque that can rupture or have their caps shear off, causing clots that lead to heart attacks. If endothelial dysfunction is detected early enough, interventions like risk factor modification and drug therapy may improve prognosis. (4)
t"The clinical evidence of an association between endothelial dysfunction and atherosclerosis and CVD is very strong," said Prasad Sunkara, Ph.D., Chief Executive Officer of Everist Genomics. "By providing an accurate assessment of endothelial function, AngioDefender may help physicians and patients to make treatment decisions aimed at reducing the risk of these serious conditions."
tSubject to securing the required regulatory approvals, Everist Genomics will commercialize AngioDefender globally, starting in Europe and India during the first quarter of 2012.
tThe current 'gold standard' for assessing endothelial function utilizes ultrasound to perform a costly and complex assessment of flow mediated dilation (FMD) of the brachial artery (BA). This type of assessment has several major limitations, such as requiring the use of expensive ultrasound equipment, a specialized ultrasound probe and a highly-trained technician. Due to these limitations, along with the time required to perform ultrasound based measurement of FMD, its use has been confined to research applications.
tAngioDefender overcomes these limitations by utilizing a patented noninvasive technology for assessing endothelial dysfunction that produces consistent results regardless of operator differences. AngioDefender assesses endothelial dysfunction by measuring changes in volume of a segment of the BA in response to a temporary occlusion of the artery. The AngioDefender test is much easier to perform than brachial artery ultrasound–the entire test can be conducted and results reported in about 15 minutes by a physician or technician–and the device will achieve a cost-savings of more than 80% when compared with brachial artery ultrasound. Importantly, several multinational studies have shown AngioDefender to correlate with Brachial Artery Ultrasound in measuring FMD. (5)
t"Our AngioDefender device has the potential to be a major advance in diagnosing and treating early stage atherosclerosis and CVD," said Prasad Sunkara, Ph.D., Chief Executive Officer of Everist Genomics. "AngioDefender has been successfully validated in several multinational studies demonstrating its accuracy and reliability in assessing endothelial function through measurement of FMD. This innovative diagnostic reflects Everist Genomics commitment to developing and commercializing high-value prognostic testing technologies that have the potential to create substantial improvements in clinical outcomes while also reducing healthcare costs," he added.
tFurther describing the financial benefits of AngioDefender, Dr. Sunkara explained that if the device resulted in only a 1% reduction in the number of people developing advanced CVD, the annual savings would be enough to recover the total cost of performing the test on 20 million Americans every year and would generate an additional $1.03 billion in annual cost savings to the healthcare system.
t"The medical community has been struggling for years to find diagnostic and treatment solutions for cardiovascular disease that improve patient outcomes in a way that is fiscally sustainable," said Dr. Sunkara. "By identifying the disease in its earliest stage, when it is most responsive to therapy and life-style modification, tests that assess endothelial function may provide the ability to finally achieve that balance."
tIn addition to identifying patients with early stage cardiovascular disease, AngioDefender might prove useful to monitor disease progression and effectiveness of cardiovascular therapies, enabling personalized dosage and treatment regimens. The test would be applicable to any patient, regardless of age, gender, ethnicity or pre-existing conditions. The test reports 25 elements of the patient record and CVD test parameters for each patient to a computer or mobile computing device for use by physicians.
tAbout Everist Genomics
tEverist Genomics is a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence and proprietary point-of-care equipment for the evaluation and management of cardiovascular disease. Using its patented Evolver™ technology platform, Everist Genomics is successfully developing and commercializing entirely new classes of patent-protected molecular biomarkers and sensor technologies which employ proprietary equipment, devices and software to help physicians make individualized treatment and drug prescribing decisions. The privately owned company is located in Ann Arbor, Michigan. For more information, please visit www.everistgenomics.com.
t(1) Journal of the American College of Cardiology Vol. 42, No. 7, 2003; The Clinical Implications of Endothelial Dysfunction; Michael E. Widlansky, MD, Noyan Gokce, MD, FACC, John F. Keaney, JR, MD, FACC, Joseph A. Vita, MD, FACC; Boston, Massachusetts
t(2) Journal of the American College of Cardiology Vol. 42, No. 7, 2003; The Clinical Implications of Endothelial Dysfunction; Michael E. Widlansky, MD, Noyan Gokce, MD, FACC, John F. Keaney, JR, MD, FACC, Joseph A. Vita, MD, FACC; Boston, Massachusetts
t(3) Sources: Weight of evidence indicates an improvement Sources: Journal of the American College of Cardiology Vol. 42, No. 7, 2003; The Clinical Implications of Endothelial Dysfunction; Michael E. Widlansky, MD, Noyan Gokce, MD, FACC, John F. Keaney, JR, MD, FACC, Joseph A. Vita, MD, FACC; Boston, Massachusetts
t(5) Moscow Medical Academy. Clinical evaluation showed strong correlation (R=0.84) between %FMD by AngioDefender with Brachial Artery Ultrasound; Medanta, Medical City. Clinical evaluation showed high degree of correlation (R=0.77) between %FMD by AngioDefender with Brachial Artery Ultrasound.
tSOURCE Everist Genomics