Automated blood test can now be used in the USA for survival prediction after myocardial infarction and assessment of failure severity in congestive heart failure
Bayer Diagnostics's fully automated blood test for B-type natriuretic peptide (BNP), for use on its Advia Centaur and ACS:180 immunoassay systems, has received clearance from the US Food and Drug Administration (FDA) for two additional claims.
One concerns the prediction of survival in patients after myocardial infarction (heart attack) in conjunction with other risk factors. The other is the assessment of heart failure severity in patients diagnosed with congestive heart failure (CHF).
The test was first cleared by FDA as an in aid in the diagnosis of heart failure in 2003.
BNP testing allows laboratories to provide GPs and cardiologists with a valuable tool for the diagnosis, prognosis and therapeutic management of CHF.
Today many more people are surviving myocardial infarctions, however many of them will later go on to develop heart failure.
The BNP molecule, which is physiologically active and can detect acute changes in the heart failure patient, provides clinicians with an accurate picture of the patient's condition at the time the blood is drawn.
This has made BNP the molecule of choice in the majority of leading heart and heart surgery hospitals in the United States.
David Morrow, Brigham and Women's Hospital, Boston, USA, was a lead investigator in a study (TIMI-23) that provided the evidence used in submitting the claim for the BNP test.
The study found significant differences in the BNP values in normal individuals versus heart failure patients in all four New York Heart Association (NYHA) classes, including the least severe Class I. The proportional increase in BNP concentration is approximately two-fold as heart failure severity increases from Class I to II, II to III, III to IV.
This differentiation led to the FDA clearing the Bayer BNP test as a tool in the assessment of severity in heart failure patients.
Dr Morrow found that if used when patients arrive at hospital, the BNP test added significant benefits to the standard tools for assessing a patient's risk of death or developing heart failure.
"The latest FDA endorsements, and the requirements for improved standards of patient care as envisaged by the National Service Framework, mean that cardiologists and GPs in the UK will be lobbying their hospital and primary care trusts to make the BNP test routinely available via their local laboratories", says Hilda Crockett, market development manager, immunochemistry, at Bayer Diagnostics.
"Laboratory managers should also be talking to their Trust Boards to emphasise the importance of providing this test in their local area.
"The BNP assay expands the comprehensive cardiovascular test panel for the Advia Centaur and gives laboratory professionals the benefit of using proven automated platforms to report results in as little as 18 minutes. "BNP tests can also be performed on an emergency (stat) basis without interruption to the other daily work in the laboratory".
The BNP test will allow CHF patients to benefit from earlier diagnosis, patients with no CHF can be ruled out and referred for appropriate treatment, and long-term cost savings can be generated by reducing demand for echocardiography and unnecessary therapy.
