The BRAHMS PCT sensitive Kryptor® test will enable ICU physicians todetermine whether an infection is bacterial or viral in nature and provideactionable information on the severity of a patient's condition less thanan hour after a blood sample is drawn. As the progression of severebacterial infections is affected by how early the patient receivesappropriate treatment, measuring PCT levels is valuable in ICUs wheresepsis represents a major health challenge.

"PCT can improve critical decisions ICU physicians have to make every day,including whether or not to administer antibiotics, thus avoidingunnecessary use of these powerful drugs and potentially reducing the lengthof stay in the ICU. Further studies will validate new standardized clinicaldecision rules that include the PCT test," said Dr. Eric H. Gluck, M.D.,Director, Critical Care Services, Swedish Covenant Hospital in Chicago.

Adding PCT to the treatment paradigm will increase the ability to quicklyassess a patient's condition, make timely treatment decisions and reducefurther complications. "We are pleased that the FDA has recognized theutility of PCT as a biomarker and the sensitivity of the Kryptorinstrument," said BRAHMS USA President and CEO, Bert Valada. "We believeits implementation will improve the current standard of care and willinevitably impact patient outcomes. The FDA decision is an importantmilestone for BRAHMS, and we look forward to introducing additionalinnovative tests to the U.S. that will improve patient care."

Numerous studies have proven the significance of a PCT test in the earlyrecognition of bacterial infection and sepsis. PCT levels are undetectablein healthy individuals. However PCT levels rise rapidly when there is thepresence of a bacterial infection. The quick results provided by theKryptor will aid healthcare professionals to make faster and better patientmanagement decisions.

About Sepsis

Sepsis is a complex clinical syndrome that is defined as the systemicinflammatory response of the body to an infection. It is the most commonunderlying cause of death in non-coronary ICUs where the mortality rate canbe as high as 32 percent or 54 percent in cases of severe sepsis or septicshock, respectively. Every year, severe sepsis (i.e., sepsis complicated byorgan dysfunction) strikes an estimated 751,000 people in the U.S. alonewith a total cost to the healthcare system of $16.7 billion (USD). Mainlyas a result of the aging of the population, the incidence of severe sepsisin the U.S. is expected to rise to close to one million by the end of thedecade. Early recognition of sepsis and timely initiation of appropriatetherapy is key for survival from this potentially devastating condition.

About Procalcitonin (PCT)

In healthy people, PCT is produced in thyroid cells as a precursor for thehormone calcitonin and cannot be found in human blood. However, bacterialinfections cause PCT to be produced by almost every organ of the body,resulting in a rapid rise of PCT levels in the blood. Viral infections donot cause this increase in PCT blood levels. The level of PCT in the bloodis a reflection of the severity of bacterial infection, ranging fromslightly elevated concentrations in infections with minor systemicinflammatory response to very high values in cases of severe sepsis andseptic shock. Once an infection is under control, Procalcitonin levelsdecrease rapidly. This makes PCT an effective tool aiding physicians in thediagnosis of bacterial infection and sepsis.

For additional information on Procalcitonin, please visitwww.procalcitonin.com.

About BRAHMS

BRAHMS products are used in hospitals and laboratories worldwide, assistingdoctors with actionable information to improve the management oflife-threatening diseases. The company researches and produces innovativeblood tests for clinical use and markets its patented products in more than50 countries around the world.

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