Medical Device Link.

Originally Published IVD Technology May 2004

INDUSTRY NEWS

With studies finding other uses for tests that measure B-type natriuretic peptide (BNP) levels, the market for BNP tests, such as the Triage BNP test by Biosite Inc. (San Diego), could be larger than expected.

Recent studies found that tests for measuring B-type natriuretic peptide (BNP) levels may have wider applications than originally intended. Two studies published in the New England Journal of Medicine concluded that BNP tests can improve patient care in an emergency setting and may be used for screening asymptomatic patients for other acute conditions. The results of these studies may indicate that the market for BNP tests may be larger than anticipated.

In one study, researchers in the emergency department (ED) at the University Hospital in Basel, Switzerland, evaluated a group of patients with symptoms of acute dyspnea. Half of these patients were diagnosed with BNP tests using a rapid bedside assay, while the other patients were not. The main factors observed for this study were time to discharge and the total cost of treatment. 

The study found that using BNP tests reduced the time to the initiation of therapy, the need for hospitalization and intensive care, the time to discharge, and the total treatment costs. Rapid BNP testing in the ED resulted in decreases in hospital admissions by 10%, median length of stay by 3 days, and mean total cost of treatment by about $1800. Overall, the study concluded that rapid BNP testing in the ED not only reduces the time to discharge and the total cost of treatment, but also improves the care of patients with acute dyspnea.

“The Basel study showed that using BNP tests early on at the point of care leads to more-efficient outcomes economically and clinically,” says Sean-Xavier Neath, MD, PhD, director of medical affairs at Biosite Inc. (San Diego). “So this test needs to be done rapidly, as soon as the patient presents to the emergency department. This is not a test that, in an acute setting, a physician can wait for an hour to do. BNP tests will also provide additional use in risk stratification to identify which patients need more-aggressive therapy and will help physicians determine the severity of the disease.

“The key message that comes out of this study is to bring BNP tests to the point of care where they can affect decision making immediately. That’s the key point, that the sooner the clinician has the information, the sooner these patients are treated, and the less likely they are to have delays in administration of medications, delays in discharge, and therefore improvements in outcome.”

In the other study, researchers from the Framingham Heart Study examined the long-term prognostic ability of BNP levels in asymptomatic patients. Researchers looked at whether BNP levels could serve as predictive indicators for increased risk of acute cardiovascular conditions such as heart failure, atrial fibrillation, stroke or transient ischemic attack, and coronary heart disease. Researchers routinely tested the BNP levels of a large sample of patients and monitored them over a period of five years for the occurrence of major cardiovascular events.

The study concluded that BNP levels could predict increased risk of a wide range of cardiovascular events. While the relation was strongest for heart failure and atrial fibrillation, the study also observed important associations between BNP levels and the risk of stroke and other major cardiovascular conditions. 

“This study provides some interesting looks into the future as to how BNP tests may be able to be used in outpatient screening,” says Neath. “The researchers demonstrated that there’s great promise for BNP tests in prognostic screening of asymptomatic patients.”

These two studies found that there are many more potential applications for BNP tests. With other candidate applications, the market for BNP tests has the potential to grow considerably.

“The future for BNP tests is going to be broader than we anticipate currently,” says Neath. “We will see coming down the road other types of uses for BNP tests, particularly in conjunction with additional biomarkers, which will provide additive value and give us more information than simply one biomarker alone.”

For more information about these studies, please access the New England Journal of Medicine’s Web site at www.nejm.org. 

Copyright ©2004 IVD Technology