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FDA clearance for automated procalcitonin test


Brahms USA Inc today announced it has received clearance from the US 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 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, MD, 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 US 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.


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