ANNAPOLIS, Md.--(BUSINESS WIRE)--BRAHMS USA, Inc today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its patented Procalcitonin (PCT) Kryptor® test. The automated test will be used in critically ill patients on the first day of ICU admission as an aid to assess their risk for progression to severe sepsis and septic shock.
The BRAHMS PCT sensitive Kryptor® test will enable ICU physicians to determine whether an infection is bacterial or viral in nature and provide actionable information on the severity of a patient’s condition less than an hour after a blood sample is drawn. As the progression of severe bacterial infections is affected by how early the patient receives appropriate treatment, measuring PCT levels is valuable in ICUs where sepsis 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 avoiding unnecessary use of these powerful drugs and potentially reducing the length of stay in the ICU. Further studies will validate new standardized clinical decision 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 quickly assess a patient’s condition, make timely treatment decisions and reduce further complications. “We are pleased that the FDA has recognized the utility of PCT as a biomarker and the sensitivity of the Kryptor instrument,” said BRAHMS USA President and CEO, Bert Valada. "We believe its implementation will improve the current standard of care and will inevitably impact patient outcomes. The FDA decision is an important milestone for BRAHMS, and we look forward to introducing additional innovative tests to the U.S. that will improve patient care.”
Numerous studies have proven the significance of a PCT test in the early recognition of bacterial infection and sepsis. PCT levels are undetectable in healthy individuals. However PCT levels rise rapidly when there is the presence of a bacterial infection. The quick results provided by the Kryptor will aid healthcare professionals to make faster and better patient management decisions.
Sepsis is a complex clinical syndrome that is defined as the systemic inflammatory response of the body to an infection. It is the most common underlying cause of death in non-coronary ICUs where the mortality rate can be as high as 32 percent or 54 percent in cases of severe sepsis or septic shock, respectively. Every year, severe sepsis (i.e., sepsis complicated by organ dysfunction) strikes an estimated 751,000 people in the U.S. alone with a total cost to the healthcare system of $16.7 billion (USD). Mainly as a result of the aging of the population, the incidence of severe sepsis in the U.S. is expected to rise to close to one million by the end of the decade. Early recognition of sepsis and timely initiation of appropriate therapy 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 the hormone calcitonin and cannot be found in human blood. However, bacterial infections 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 do not cause this increase in PCT blood levels. The level of PCT in the blood is a reflection of the severity of bacterial infection, ranging from slightly elevated concentrations in infections with minor systemic inflammatory response to very high values in cases of severe sepsis and septic shock. Once an infection is under control, Procalcitonin levels decrease rapidly. This makes PCT an effective tool aiding physicians in the diagnosis of bacterial infection and sepsis.
For additional information on Procalcitonin, please visit www.procalcitonin.com.
BRAHMS products are used in hospitals and laboratories worldwide, assisting doctors with actionable information to improve the management of life-threatening diseases. The company researches and produces innovative blood tests for clinical use and markets its patented products in more than 50 countries around the world.
BRAHMS USA, Inc
Dave Schemelia, 646-722-8819