Bayer HealthCare, Diagnostics Division, a member of the Bayer Group and Inverness Medical Innovations, Inc., a leading manufacturer and marketer of professional and consumer medical diagnostic products, have signed four agreements to broaden their assay menu offerings worldwide in the diagnostics arena.

The first agreement will expand access for physicians and healthcare providers worldwide, excluding Japan, to diagnose congestive heart failure using a point of care assay for B-type Natriuretic Peptide (BNP) testing, claims a company release.

Recent research has shown that elevated levels of BNP are an indicator of heart failure, thus providing physicians with an important diagnostic tool in the early detection and management of heart failure.

BNP is a rapidly expanding area for cardiovascular testing. The BNP molecule is physiologically active serving as a direct biological response to cardiovascular stress. This attribute allows BNP testing to provide a representation of a patient’s cardiac situation at the time a blood sample is drawn, which in turn allows for more timely treatment and patient management. The use of BNP as an effective tool in the prognosis and management of heart failure makes it the molecule of choice.

“Bayer Diagnostics is looking forward to working with Inverness to help fight congestive heart failure with the BNP assay. The BNP assay is an example of Bayer’s ongoing commitment to improving life through scientific innovation. We hope to drive the benefits of BNP testing to patients and healthcare providers globally,” stated Tom Warekois, senior vice president of global strategic marketing for Bayer Diagnostics.

“We are very pleased to be able to work with Bayer in developing and producing point of care tests using BNP as a marker for congestive heart failure,” said Ron Zwanziger, CEO of Inverness. “Used in combination with our urotensin marker, we believe that Inverness and Bayer will have a potentially strong position in the early diagnosis of congestive heart failure in both near patient and laboratory markets.”

The second agreement grants Bayer an option to commercialise Inverness’ proprietary urotensin marker on its automated immunoassay systems worldwide. Preliminary evidence indicates that urotensin, when used in conjunction with BNP, may be of significant value in improving the specificity of early diagnosis of congestive heart failure.

The third agreement calls for Inverness and Bayer to work together in developing an application of the Inverness Ischemia Modified Albumin (IMA) test for worldwide use on Bayer’s automated Advia chemistry analyser. IMA is a proprietary serum marker that assists in the early evaluation of acute coronary syndrome (ACS) prior to heart attack in patients presenting to hospital emergency departments with chest pain. There are over 6 million such visits each year in the United States alone with the number rising by about 10 per cent a year.

The final agreement grants Bayer non-exclusive rights to an Inverness hybridoma cell line capable of producing monoclonal antibodies against the envelope protein of the Hepatitis B virus (HBe). The agreement provides Bayer the right to use tests employing this monoclonal antibody on its automated immunoassay systems.

Bayer HealthCare, in 2003, received FDA clearance for its fully-automated BNP test as an aid in the diagnosis of heart failure. The following year, Bayer HealthCare received FDA clearance for two added claims - the prediction of survival in patients after myocardial infarction and assessment of heart failure severity in patients diagnosed with congestive heart failure.