KIRKLAND, Wash.—Prevencio has released data demonstrating high accuracy for its multiple-protein HART AKI (acute kidney injury) test. Researchers believe these important findings, presented November 10th at the 2018 American Heart Association (AHA) Scientific Sessions in Chicago, will lead to more accurate prediction of AKI risk. This has the potential to alter patient management and reduce the alarming incidence of AKI.
In this study, researchers evaluated the company’s AI-driven HART AKI test on 889 patients undergoing cardiac catheterization in Massachusetts General Hospital’s (MGH) Catheter Sampled Blood Archive in Cardiovascular Disease (CASABLANCA) study. The HART AKI test algorithmically interprets six clinical and protein variables (history of diabetes, blood urea nitrogen to creatinine ratio, C-reactive protein, osteopontin, CD5 antigen-like, and Factor VII). The HART AKI had an impressive negative predictive value of 98% and an overall accuracy measurement of 82% (AUC=0.82).
Principal investigator James L. Januzzi, MD, practicing cardiologist at MGH and Professor of Medicine at Harvard Medical School, said, “AKI following coronary angiographic procedures is associated with significant morbidity and death. A test that accurately predicts risk for AKI is of great value, as it can alter patient management; this might include minimizing dye exposure and increasing pre-procedure hydration. In patients with diabetes or heart failure, where risk for Chronic Kidney Disease (CKD) is higher, a high HART AKI score may lead to delaying elective angiography plans until such comorbidities are better managed. Additionally, we believe HART tests could also play an important role in identifying high risk patients for enrollment in clinical trials, thereby saving time and lowering overall trial costs.”
Cardiac catheterization (also called cardiac cath or coronary angiogram) is an invasive imaging procedure that allows doctors to evaluate blood flow to the heart. During cardiac catheterization, a thin tube, called a catheter, is inserted in an artery or vein, usually in the groin area, and is threaded through the blood vessels to the heart. Contrast dye is injected for imaging, and is the primary cause of AKI.
The number of cardiac catheterization or percutaneous coronary intervention (PCI) cases resulting in AKI rose almost threefold from 2001 to 2011. Prediction and prevention strategies, such as the HART AKI test, are needed to reverse this alarming rise in AKI.
“This AHA presentation adds to the growing volume of presented and published peer-reviewed, scientific literature supporting the accuracy and clinical benefit of our novel AI-driven HART tests,” noted Rhonda Rhyne, Prevencio’s Chief Executive Officer. “We have had an unprecedented ten presentations and publications over the past two years. The potential of our HART tests to fulfill the urgent need for alternative, reliable, and cost-effective cardiovascular diagnostic and monitoring solutions is encouraging.
“On behalf of the Prevencio team, I would like to extend sincere gratitude to Massachusetts General Hospital, Dr. Januzzi and his researchers, and Myriad RBM for their significant contributions and continued dedication in developing and validating Prevencio’s novel HART tests,” added Rhyne. “With our ongoing positive HART test results, we are fulfilling our mission of revolutionizing blood tests for cardiovascular disease—powered by AI.”
Employing the AI approach, the company has produced six blood tests to date that significantly improve diagnoses for a variety of heart and blood vessel-related complications. These tests are: HART CAD for obstructive coronary artery disease diagnosis; HART CVE for 1-year risk of heart attack, stroke or cardiac death; HART PAD for peripheral artery disease diagnosis; HART AS for aortic valve stenosis diagnosis; HART AMP for risk of amputation; and HART AKI for risk of acute kidney injury.