B·R·A·H·M·S receives final FDA clearance to market Procalcitonin (PCT)  

Atlanta, GA - Feb. 21, 2005 B·R·A·H·M·S Diagnostica, LLC announces receipt of final notification of market clearance in the U.S. for its inflammatory response marker in sepsis, B·R·A·H·M·S PCT LIA.

The B·R·A·H·M·S PCT LIA, which is already in use in numerous European hospitals, is now available to U.S. doctors for the early diagnosis of patients at risk for progression to severe sepsis.

"This represents an important milestone for our future economic development as a company. We are assuming that physicians in the U.S., like their European colleagues, will evaluate the benefits of this reliable and innovative diagnostic device positively in the battle against one of the most deadly illnesses", a Member of the Management Board of B·R·A·H·M·S stated today.

Early diagnosis and appropriate therapy of sepsis is a daily challenge in intensive care units. Severe sepsis (sepsis with acute organ dysfunction) is the number one cause of death in the non-coronary intensive care unit. Today, more than 750,000 Americans develop severe sepsis each year equaling more than 2,000 new cases per day in the U.S. alone. Cases of severe sepsis are expected to rise partly due to the widespread use of antibiotics which encourages the growth of drug resistant microorganism. Despite the enormous investment in critical care resources, severe sepsis mortality ranges from 28% to 50% or greater.

Numerous international studies and tests were able to prove the high significance of the Procalcitonin (PCT) test in the early recognition and therapy direction of severe bacterial infections (sepsis). The results of further high-ranking studies are shortly to be published.

Dr R. Phillip Dellinger (Camden, NJ), Director of Section of Critical Care Medicine at Cooper University Hospital commented on Procalcitonin: "It is clear that elevation in procalcitonin offers the clinician a significant correlation with infection and severity of infection. Clinical utility in select patient populations has already been identified and our center and others continue to work to discover the optimal utilization of this marker as it relates to patient management."

Prof. Konrad Reinhart (Jena, Germany), clinical scientific pioneer in Procalcitonin (PCT) testing stated: "We have always been very confident that the Procalcitonin test would provide excellent clinical potential. Today, this test has established a place in our clinical routine for the diagnosis and therapy direction of sepsis. The availability of PCT in the U.S. will encourage more international clinical-scientific cooperation on this subject."

B·R·A·H·M·S is a European biotech research company located in Berlin, Germany. The company researches and produces innovative diagnostic tests for clinical use and markets its products in over 50 countries worldwide. B·R·A·H·M·S holds the international patents for Procalcitonin (PCT) as well as for other innovative products.

For further information on Procalcitonin, please visit www.procalcitonin.com


USA: B·R·A·H·M·S  Diagnostica, LLC
Jonas Leichtner
Marketing Director U.S.

International: B·R·A·H·M·S  Aktiengesellschaft
Dr. Jutta Odarjuk
Senior Marketing Manager Intensive Care