Prevencio, Inc., announces the publication of data that demonstrates a simple new blood test accurately diagnoses significant Peripheral Artery Disease (PAD), a circulatory problem in which plaque-narrowed arteries reduce blood flow to a patient's limbs and kidneys. If left untreated, PAD can lead to clogged arteries and increase the risk of a major cardiac event or amputation. Researchers believe the data, published in Clinical Cardiology, could lead to the use of this test as a gatekeeper to imaging or invasive testing, thus reducing cost and exposures to potentially harmful intravenous contrast and/or ionizing radiation.
In the study, Massachusetts General Hospital and Prevencio researchers developed and validated a multi-protein blood test, HARTTM PAD, that identifies the presence of PAD and predicts the need for a future medical intervention. Principal Investigator James L. Januzzi, MD, is a practicing cardiologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School.
Januzzi and a team of researchers tested 355 patients referred for diagnostic peripheral angiography to Massachusetts General Hospital. When divided into low-risk and high-risk categories, the HART PAD test predicted with 98 percent accuracy to exclude obstruction of the peripheral arteries. Additionally, the test predicted with 86 percent accuracy to identify obstruction of the peripheral arteries.
"This blood test may allow for the diagnosis and treatment of many more patients with PAD," said Januzzi. "As well as giving physicians the opportunity to provide patients with more appropriate care, we believe the test could also benefit clinical trials by saving time and thereby lowering overall trial costs."
PAD affects more than 202 million people globally and is often underdiagnosed and undertreated until the disease has reached its advanced stages. In addition to the HART PAD test, Prevencio is developing a multi-protein blood test, HART AMP, to specifically identify a patient's risk for amputation.
"We are pleased to have our third publication validating the high accuracy of our HART tests which have the potential to improve treatment for millions of cardiovascular patients," said Rhonda Rhyne, Prevencio's Chief Executive Officer. "This could not have been accomplished without our collaboration with Dr. Januzzi and his researchers and Myriad RBM. It is also highly rewarding to work on our HART biomarker blood tests with pharmaceutical companies to test drug efficacy, improve drug development, and decrease clinical trial expenses."
Powered by AI, Prevencio is revolutionizing blood tests for cardiovascular disease. Employing this novel approach, the company has produced five blood tests to-date that significantly improve diagnoses for a variety of heart and blood vessel-related complications.
These tests are:
1. HART CADTM - obstructive coronary artery disease diagnosis
2. HART CVETM - 1-year risk of heart attack, stroke or cardiac death
3. HART PADTM - peripheral artery disease diagnosis
4. HART ASTM - aortic valve stenosis diagnosis
5. HART AMPTM - risk of amputation
HART test results have been presented at leading cardiovascular meetings—(European Society of Cardiology Congress Scientific Sessions - 2016, American College of Cardiology Scientific Sessions - 2017, American Heart Association Scientific Sessions - 2017, American College of Cardiology Scientific Sessions - 2018, American Diabetes Association Scientific Sessions - 2018) and published in top-tier cardiology journals (Journal of American College of Cardiology - March 2017, American Journal of Cardiology - July 2017, and Clinical Cardiology, June 2018).