FDA Submission of B-R-A-H-M-S MR-proANP Kryptor
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
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
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 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 firstname.lastname@example.org
SOURCE B-R-A-H-M-S Aktiengesellschaft