Navigation Links
FDA Submission of B-R-A-H-M-S MR-proANP Kryptor
Date:3/6/2009

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(R), the company's FDA-cleared marker for sepsis. The B-R-A-H-M-S PCT sensitive Kryptor(R) 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 visithttp://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


'/>"/>
SOURCE B-R-A-H-M-S Aktiengesellschaft
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmaxis Announces New Drug Application Submission for Aridol(TM)
2. MannKind Updates Status of NDA Submission for AFRESA
3. Kensey Nash Announces IDE Submission for Cartilage Repair Device
4. Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission
5. Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback
6. Alfacell Provides ONCONASE(R) NDA Submission Update
7. FDA Reviewing Biomoda Submission for Cancer Screening Study
8. AMT Prepares for Submission of Marketing Authorization Dossier for AMT-011 (Glybera(R))
9. Columbia University Medical Center and Rosetta Genomics Announce Columbia Universitys Submission of the First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology for Approval to the New York State Department of Health Clinica
10. Synbiotics Corporation Announces Human Submission for FluDetect(R)
11. FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 Any dentist who has made an implant ... process. Many of them do not even offer this as ... high laboratory costs involved. And those who ARE able to ... a high cost that the majority of today,s patients would ... Parsa Zadeh , founder of Dental Evolutions Inc. and inventor ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
(Date:6/23/2016)... June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations ... Latin America . ... ... ... ...
Breaking Medicine Technology:
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... Lewisville, TX (PRWEB) , ... June 25, 2016 , ... ... in the United States, named Dr. Sesan Ogunleye, as the Medical Director of its ... be the facility Medical Director of our new Mesquite location,” said Dr. James M. ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine ... Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor ... Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With this ...
Breaking Medicine News(10 mins):