Data published in the Journal of the American College of Cardiology shows a new blood test detected a significant coronary obstruction 90% of the time, and also tipped doctors off to a patient's risk of a future heart attack.
A Massachusetts General Hospital cardiologist said Prevencio Inc.'s multi-protein blood test could represent a new standard of care for diagnosing heart disease and predicting heart attack risk.
A new blood test could change the way doctors diagnose heart disease, and potentially offer a heads up about future heart attacks. According to data published in the Journal of the American College of Cardiology, the test is substantially more accurate for heart disease diagnosis compared to standard diagnostic methods like ECG and nuclear stress testing, and results are delivered in just two hours.
Kirkland, WA-based Prevencio Inc. developed the multi-protein blood test with researchers from the Massachusetts General Hospital to diagnose a patient's likelihood of having coronary artery disease (CAD), which could require invasive intervention to prevent a possible heart attack or death.
James Januzzi, a cardiologist at Massachusetts General Hospital and a professor of medicine at Harvard Medicine School, led a team of researchers that tested more than 900 patients for the presence of obstruction of 70% or more in at least one major coronary artery, which is the threshold for medical intervention. A positive result with the new test indicated the presence of significant coronary obstruction 90% of the time, and also tipped the clinicians off to a patient's risk of a future heart attack.
"These are significant results which have the potential to establish a new standard of care and the potential to save millions of lives," Januzzi said.
He said better diagnostic and predictive methods could lead to earlier therapy and lifestyle changes, which in turn could prevent heart attacks and improve a patient's quality of life.
Prevencio said standard diagnostic methods such as ECG and nuclear stress tests are problematic because they can be inaccurate in women and obese patients, and nuclear tests expose patients to ionizing radiation. These standard methods are not cheap either. A cardiac CT angiogram procedure runs about $2,000 on average, and a cardiac catheterization costs roughly $47,000 on average in the United States. Pointing to other research published in the New England Journal of Medicine, almost 65% of patients are needlessly referred for invasive coronary catheterization.
In addition to the Hart CAD test for diagnosis, Prevencio is developing blood tests for predicting, and ideally preventing, the likelihood that a patient will have a heart attack, stroke, or cardiovascular death within one year.
Prevencio is developing its standardized lab test for Hart CAD and plans to conduct FDA trials in 2018, then file for European and FDA approval between 2018 and 2019.
Current cardiac blood tests are designed to analyze one individual protein at a time, but Prevencio's tests are designed to analyze multiple proteins and algorithmically scores a patient to determine the absence or presence of heart CAD, as well as predict their one year risk for heart attack, stroke, or cardiovascular death.
While the ultimate goal of Prevencio's tests is to prevent heart attacks, other companies are working on ways to improve the diagnosis of heart attacks that are already happening. Last year, for example, Philips introduced a heart attack detector that runs on one drop of blood.
Amanda Pedersen is Qmed's news editor. Contact her at [email protected].
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