Diagnostics & Imaging Week

Roche Diagnostics (Indianapolis) has received FDA clearance for what the company says is the first and only natriuretic peptide test to be green-lighted by the FDA for risk assessment of cardiac events in people with stable coronary artery disease.

The company said that nearly 13 million people in the U.S. have stable coronary artery disease, making them more susceptible than the general population for the development of adverse cardiac events.

"This additional application for use of NT-proBNP provides significant opportunities to help patients and their physicians learn more about their cardiac status and their cardiac risk," said Mike Samoszuk, MD, chief medical officer of Roche Diagnostics, in a prepared statement. "Millions of people in the U.S. have a high risk of developing cardiac events, because they have stable coronary artery disease.

He added: "Since this is an early marker of cardiac involvement in these disease processes, once a person is identified to be at cardiac risk, they can work with their physician to determine the best treatment and therapy early on. Laboratory tests like this are changing the way physicians approach patient care."

The test is designed to run on Roche's Elecsys systems and Modular Analytics E170 immunoassay analyzers.

A spokeswoman for Roche in an email to Diagnostics & Imaging Week wrote that the FDA clearance was granted based on "three large studies with a total of 2,997 subjects." Researchers measured proBNP levels and followed patients for a mean follow-up of five years.

Ischemia is considered to cause the heart to release NT-proBNP, she said, thus providing an indicator of damage or other problems putting the individual at risk.

"After adjusting for other co-variables [such as age, gender or body mass index], Elecsys NT-proBNP remained a strong independent predictor of cardiovascular morbidity and mortality," she wrote, including angina, heart attack and heart failure.

Roche's proBNP test is also cleared as an aid in the diagnosis of individuals suspected of having congestive heart failure and as a marker of risk for patients with acute coronary syndrome and congestive heart failure, the company said.

Roche also said it has moved to the No. 1 position in the cardiac marker market globally, though it does not provide market data on specific tests.

In February of last year, the diagnostics division of Abbott Laboratories (Abbott Park, Illinois) entered a licensing agreement with the Cleveland Clinic (Cleveland) for the development of an automated in vitro diagnostic test to detect myeloperoxidase, an enzyme found in white blood cells that can determine patients who are in imminent danger of heart attack or death. The test was approved by the FDA in June.

In August, Olympus (Melville, New York) said it received clearance for its C-reactive protein marker test, which is designed to assess the risk of recurrent events in people with either stable coronary disease or acute coronary syndromes.

According to the National Heart, Lung and Blood Institute (Bethesda, Maryland), coronary artery disease is the most common type of heart disease and the leading cause of death in the U.S. in both men and women.