News | March 20, 2009

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

Related Content

Alere point of care POC testing for INR
News | Point of Care Testing| July 17, 2017 | Dave Fornell
July 17, 2017 — Despite issues with point-of-care INR testing company Alere Inc., Abbott announced this week it is on
Siemens Xprecia Stride anticoagulation, coagulation PT/INR or INR testing at the point of care (POC)

Point-of-care coagulation PT/INR testing with handheld devices can help improve outcomes with more convenient and frequent measurements to keep patients within the therapeutic range of anticoagulant agents.

Feature | Point of Care Testing| May 05, 2017 | Nicholas C. Vanderslice, Ph.D., and Arnol S. Rios
Point-of-care (POC) coagulation analyzers that measure prothrombin time/international normalized ratio (PT/INR) on fi
Patients With Low Corus CAD Test Score Less Likely to Undergo Cardiac Referra
News | Blood Testing| May 02, 2017
CardioDx Inc. recently announced the publication of results from the multi-center, community-based PRESET Registry in...
New Blood Test Predicts Major Cardiac Events Better Than Clinical Evaluation of Other Common Risk Factors
News | Blood Testing| April 28, 2017
Prevencio Inc. announced the publication of data demonstrating that a simple new blood test is more accurate than...
New Study Pursues Universal Sample Bank for Troponin Tests
News | Blood Testing| April 13, 2017
April 13, 2017 — A study published recently in the American Association for Clinical Chemistry’s (AACC)...
PTS Diagnostics, FDA 510k clearance, extended HDL range, lipid panel test strips
News | Blood Testing| April 05, 2017
PTS Diagnostics announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded top range for...
warfarin dosing, genetic testing, adverse event risk, ACC.17, clinical study
News | Antiplatelet and Anticoagulation Therapies| March 27, 2017
Using genetic testing to help personalize warfarin therapy given to patients undergoing elective orthopedic surgery...
highly sensitive troponin testing
News | Cardiac Diagnostics| March 21, 2017
March 21, 2017 — A blood test for a protein called high-sensitivity troponin T, which is released into the bloodstrea
heart attack evaluation, blood test, HEART Score, ER, emergency room, Circulation Cardiovascular Quality and Outcomes study
News | Blood Testing| March 01, 2017
Up to 40 percent of emergency room (ER) patients with chest pain can safely go home in a little under 2 hours, using a...
troponin blood test, heart disease risk, heart attack, British Heart Foundation, BHF
News | Blood Testing| January 04, 2017
A high-sensitivity blood test could be used to predict which patients are at risk of a heart attack according to new...
Overlay Init