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news.Brahms USA has received 510(k) clearance from the FDA to market its patented Procalcitonin 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.
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The Brahms Procalcitonin (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.
Adding PCT to the treatment paradigm is said to increase the ability to assess a patient’s condition, make timely treatment decisions and reduce further complications.
Bert Valada, president and CEO of Brahms USA, said: “We are pleased that the FDA has recognized the utility of PCT as a biomarker and the sensitivity of the Kryptor instrument. 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.”