BRAHMS Submits Congestive Heart Failure Marker for FDA Approval
March 20, 2009 - BRAHMS AG of Hennigsdorf, Germany and Annapolis, MD, recently submitted a 510(k) file to the FDA to market its patented BRAHMS MR-proANP Kryptor Test used to find biomarkers for heart failure.
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). The study, which included 1,641 patients experiencing shortness of breath at participating emergency rooms, demonstrated MR-proANP was an excellent marker for diagnosing congestive heart failure. It also provides additional information especially in diagnostically challenging subgroups such as obesity, higher age or renal dysfunction to routinely used markers.
The results of the BACH-trial, which were first presented at the 2008 ESC Congress, shows the company’s biomarker tests are effective, 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 the first half of 2008.
For more information: www.brahms.de, www.brahms-usa.com