Bayer BNP assay receives FDA clearance for two additional heart failure claims

Main Category: Cardiovascular / Cardiology
Article Date: 20 Sep 2004 - 10:00 PDT

email to a friend   printer friendly   opinions  

Bayer Diagnostics' 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:

-- the prediction of survival in patients after myocardial infarction, or heart attack in conjunction with other risk factors; and

-- 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 (ref 1).

Dr. 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 2-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.

For more information contact Hilda Crockett: Email:
hilda.crockett.hc@bayer.co.uk

ENDS

ADVIA and Centaur are trade marks of Bayer Corporation, USA.

Reference:
1. "America's Best Hospitals. The Honor Roll", 28 July 2003, US News and World Report.

NOTES FOR EDITORS:

a) Background:

The management of CHF accounts for 2% of the NHS budget, about two-thirds of which are hospital costs. 5% of all medical admissions to hospital are related to the condition, and readmission rates have been estimated to be as high as 50% over three months. About half of these admissions may be preventable according to the NSF, which also acknowledges that many patients suffer from CHF that has not been recognised or appropriately treated.

There is also evidence that some people who are treated do not have heart failure.

The NSF calls on all primary care teams to ensure that written protocols are in place for the management of patients with suspected CHF including the methods and indications for accessing investigations such as echocardiography, ECG and biochemical tests. Such protocols are intended to provide structured and continually improving care to people with CHF.

The availability of the new BNP test has been well publicised in the UK's national and clinical press and BNP has been a major topic at many clinical meetings. As a result GPs and cardiologists are now beginning to recognise the BNP test's potential as a new 'gold standard' for heart failure.

Worldwide trials using the ADVIA Centaur® BNP assay by cardiologists have established that when concentration of BNP is 100pg/mL the specificity of the test is greater than 96%. When used as a diagnostic tool alongside physical examination, patient history and other non-invasive procedures, it can make a significant contribution to the differential diagnosis of CHF and the selection and monitoring of therapy (Bluestein B. et al. BNP: a new tool for the diagnosis, prognosis and therapeutic management of heart failure patients. Bayer HealthCare LLC, Diagnostics Division). The European Society of Cardiology has approved the use of BNP measurements as an aid in the screening and diagnosis of heart failure.

The ADVIA® Centaur® is a chemiluminescence system which automates a complete portfolio of thyroid, anaemia and fertility immunoassays, as well as assays for cancer, cardiac analysis, allergy testing and therapeutic drug monitoring. The system automatically tests and tracks bar-coded samples and offers direct interfacing to laboratory information systems. Initial test results are provided within 18 minutes, with subsequent results every 20 seconds.

The ACS:180® Immunoassay System is utilized by laboratories worldwide, testing for a broad range of conditions, including cancer, cardiovascular diseases, fertility, anaemia, thyroid diseases, allergy, autoimmune, metabolic diseases, therapeutic drug monitoring and infectious diseases.

b) Further information:

If you require any further information please quote ref BD052 and contact:

Pam Simmons
Mackintosh Lloyd Limited
4 Oakway Drive
Frimley
Surrey GU16 8LF, UK
mailto:pamsimmons@ntlworld.com
T: +44 (0) 1276 506706
F: +44 (0) 1276 506737

• Additional
• References
• Citations