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FDA Submission of B·R·A·H·M·S' MR-proANP Kryptor


3/6/2009 7:55:29 AM

HENNIGSDORF, Germany, March 6 /PRNewswire/ -- B-R-A-H-M-S Aktiengesellschaft today announced it has submitted 510(k) file to the U.S. Food and Drug Administration (FDA) to market its patented B-R-A-H-M-S MR-proANP Kryptor Test.

Atrial Natriuretic Peptide (ANP) is predominantly produced in the atrium of the heart and comprises 98% of the natriuretic peptides in the circulation. ANP is involved in natriuresis, diuresis, vasodilation and cardiovascular homeostasis. Although this peptide is unstable, the B-R-A-H-M-S-assay detects the corresponding prohormone fragment: the Mid-Regional pro-Atrial Natriuretic Peptide (MR-proANP). In contrast to the mature peptide, MR-proANP is a stable and reliable surrogate measurement of atrial natriuretic peptide levels.

The clinical benefits of MR-proANP were analyzed within an international, multi-center, prospective, multi-marker trial called BACH (Biomarkers in Acute Congestive Heart Failure). Enrolling 1641 patients presenting with shortness of breath to participating emergency rooms the study demonstrated MR-proANP to be a highly useful marker for diagnosing congestive heart failure. Furthermore it provides additional information especially in diagnostically challenging subgroups such as obesity, higher age or renal dysfunction compared to routinely used markers.

First presented at the 2008 ESC Congress and subsequently at the 2008 AHA annual meeting, the results of the BACH-trial confirm the company's commitment to improving healthcare through highly effective biomarker tests and complement the success of the Procalcitonin Kryptor, the company's test for the diagnosis of severe bacterial infections, introduced in the U.S. in early 2008.

B-R-A-H-M-S is a global biotechnology company committed to improving healthcare through the discovery and development of new, innovative biomarkers for the diagnosis, treatment and therapeutic management of life-threatening diseases. With its more than 400 employees, the company's goal is to extend its large portfolio of new biomarker tests for infectious and cardiovascular diseases as well as other clinical applications. B-R-A-H-M-S develops and markets its patent-protected products worldwide to hospitals, laboratories and licensees. B-R-A-H-M-S AG has its headquarters in Hennigsdorf near Berlin, Germany.

B-R-A-H-M-S USA, the wholly-owned subsidiary of B-R-A-H-M-S AG, markets Procalcitonin®, the company's FDA-cleared marker for sepsis. The B-R-A-H-M-S PCT sensitive Kryptor® test enables physicians to determine whether an infection is bacterial or viral in nature and provides actionable information on the severity of a patient's condition less than an hour after a blood sample is drawn.

For more information, please visit http://www.brahms-usa.com and http://www.brahms.de.

Contact: B-R-A-H-M-S USA, Inc. Richard Hockins +1-410-897-9960 r.hockins@brahms-usa.com


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