Healthcare Industry News:  Acute Coronary Syndrome 

Diagnostics Cardiology FDA

 News Release - January 31, 2006

Bayer Diagnostics Announces First Fully-Automated High Sensitivity and High Precision Troponin Assays

TnI-Ultra(TM) Assays Contribute to Higher Levels of Sensitivity and Precision Increasing Confidence in Management of Patients Suspected of Myocardial Infarctions (MI)

TARRYTOWN, N.Y., Jan. 31 (HSMN NewsFeed) -- Bayer HealthCare, Diagnostics Division, a member of the Bayer Group (NYSE: BAY ), announced today that they have received FDA clearance on two new Troponin-I assays (TnI-Ultra(TM)). The TnI-Ultra assays are the first fully-automated Troponin assays meeting the European Society of Cardiology/American College of Cardiology recommendation of a less than or equal to 10% level of imprecision at the 99th percentile of a healthy population. Meeting the ESC/ACC criteria is a key attribute in the definition of a high sensitivity Troponin test. The TnI-Ultra assay has been cleared on Bayer's ADVIA IMSŪ 800i and ADVIA CentaurŪ Immunoassay System. These assays aid physicians in the diagnosis of Myocardial Infarction (MI) and the assessment of risk in patients with Acute Coronary Syndrome.

The ADVIA IMS and the ADVIA Centaur Immunoassay TnI-Ultra assays have the same 99 percentile value and show the equivalent precision at this very low level. This strong concordance between assays allows for equivalent results in core and satellite laboratory situations. The high degree of precision seen with the TnI-Ultra assays is expected to show an increased level of accuracy, contributing to improved patient care in those suspected of MI.

Bayer has a strong heritage of TnI "firsts" as they were also the first to receive FDA clearance of their cTnI assay in the risk stratification of patients with non-ST segment elevation Acute Coronary Syndromes.

"The addition of TnI-Ultra to the cardiovascular menu meets customers' needs for a troponin assay that meets ESC/ACC guidelines and strengthens Bayer's already impressive portfolio -- which includes CK-MB, Myoglobin, Homocysteine, and BNP -- allowing for workstation consolidation and rapid turnaround of results on highly productive Immunoassay systems," said Tom Warekois, Senior Vice President of Global Strategic Marketing for Bayer HealthCare's Diagnostics Division.

Prevalence of Heart Attacks

Heart attacks are a serious, sudden heart condition usually characterized by varying degrees of chest pain or discomfort, weakness, sweating, nausea, vomiting, and arrhythmias, sometimes causing loss of consciousness (1). Heart attack occurrences are on the rise and have become a growing concern worldwide (1). According to the American Heart Association, an estimated 700,000 Americans will have a new heart attack and an estimated 500,000 will have a recurrent attack annually. It is estimated that an additional 175,000 silent first heart attacks occur each year (1).

About Bayer HealthCare, Diagnostics Division

Bayer HealthCare, Diagnostics Division (http://www.bayerdiag.com), based in Tarrytown, New York, U.S.A., is one of the largest diagnostic businesses in the world. The organization supports customers in 100 countries through an extensive portfolio of laboratory testing, molecular testing and near patient care diagnostics systems and services for use in the assessment and management of health, including the areas of cardiovascular and kidney disease, oncology, virology and women's health. Bayer HealthCare Diagnostics Division's global headquarters in the United States operates as part of Bayer HealthCare LLC, a member of the worldwide Bayer HealthCare group.

About Bayer HealthCare AG

Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.

The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology; Oncology and Primary Care.

Bayer HealthCare employed 35,300 people worldwide in 2004.

Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.

(1) American Heart Association. Heart Disease and Stroke Statistics -- 2006 Update. Dallas, Tex.: American Heart Association; 2004.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


Source: Bayer HealthCare

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.