Automated B-type Natriuretic Peptide (BNP) assay gains FDA approval for use in the diagnosis of heart failure as seminar speakers acknowledge clinical utility of the test
Bayer Diagnostics' new B-type Natriuretic Peptide (BNP) assay has received clearance from the US Food and Drug Administration (FDA) for use as an aid in the diagnosis of heart failure.
The assay, developed for use on the Advia Centaur immunoassay system, is the first fully automated BNP assay to receive such approval.
During heart failure, proBNP, the precursor of BNP, is released from the ventricles of the heart into the bloodstream as a compensatory response to increased blood pressure and volume overload.
As proBNP enters the bloodstream, it is cleaved into two fragments: BNP and NT-proBNP. BNP, the molecule measured by the Advia Centaur test, is the physiologically active molecule and the one that counter acts the deleterious effects of this intra-cardiac pressure.
NT-proBNP is the inactive by-product of the split of proBNP.
Because the Advia Centaur BNP assay measures the direct biologic response to cardiovascular stress, it allows for a more direct reflection of the heart failure patient's current status, providing physicians with confidence in patient management and clinical decision-making.
The value of BNP analysis in the diagnosis, prognosis and therapeutic management of heart failure was highlighted recently in a series of poster presentations at the 15th International Federation of Clinical Chemistry (IFCC) meeting in Barcelona.
The benefits of using the Advia Centaur BNP assay were highlighted in these posters with special emphasis on the high analytical precision and excellent negative predictive value in rule-out of heart failure with the Bayer assay.
A poster presented by Richard Spooner and his colleagues from North Glasgow University Hospitals NHS Trust stated that: "It is anticipated that BNP will allow a significant triage to take place at the level of general practice with consequent cost savings".
The conclusion to this poster acknowledged the need for robust assay systems for routine BNP measurements to assist cardiologists in prioritising their services to patients with suspected heart failure.
"The Bayer Advia Centaur offers such a platform with precise BNP assays over a wide dynamic range and an 18 minute turnaround", it states.
A poster was also presented in Barcelona detailing a comparison of the Advia Centaur BNP assay with the Roche Elecsys pro-BNP method by R John et al from the University Hospital of Wales.
"BNP as an aid to the diagnosis of heart failure and to monitor the efficacy of treatment can now be measured with high precision, fast turnaround times and on automated immunoassay analysers", it concludes.
"It shows good correlation with pro-BNP particularly at increased concentrations". Demand for the BNP test is increasing rapidly in the UK, where GPs and cardiologists are now beginning to recognise its potential as a new 'gold standard' for heart failure. "It is now widely acknowledged that measurement of BNP can help to achieve delivery of the improved standards of patient care envisaged by the National Service Framework for Coronary Heart Disease", says Hilda Crockett, Bayer's marketing manager for chemistry and immunoassay products. "Availability of this test not only benefits patients by facilitating earlier diagnosis, but also has the potential to generate long-term cost savings by reducing demand for echo cardiography and inappropriate therapy".
This view was reflected at the BNP workshop which Bayer recently facilitated at the 2003 ACB Focus meeting, where Theresa McDonagh, senior lecturer (clinical) in medical cardiology and honorary consultant cardiologist at the Royal Infirmary, Glasgow, described the business case being put forward in her local Trust for the introduction of a routine BNP testing service.
According to Dr McDonagh, echocardiogram services are currently costing the Trust approximately £500,000 per annum, with consultant episodes adding a further £500,000.
While the provision of a BNP testing service would cost an estimated £36,000 per annum, it could potentially realise a saving of £500,000 in reduced echo referrals for North Glasgow and £1 million for Glasgow as a whole.
Bayer's BNP assay incorporates antibodies supplied by Shionogi.
As a rapid, precise high-throughput method which takes just 18 minutes to complete on the Advia Centaur immunoassay system, it allows BNP measurements to become a routine part of a laboratory's testing repertoire.
