FDA clearance expands clinical claims of Thermo Scientific B•R•A•H•M•S PCT biomarker for sepsis risk assessment

Procalcitonin assay cleared for assessing mortality risk of septic patients over multiple days, aiding in critical care patient management

Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) that expands the clinical claims of the Thermo Scientific B·R·A·H·M·S PCT (procalcitonin) biomarker assay for sepsis risk assessment. PCT is a sensitive and specific biomarker of systemic bacterial infection. Clinicians can now use B·R·A·H·M·S  PCT to help assess the response of septic patients to treatment by comparing a baseline PCT measurement with a PCT value taken on day four. The change in PCT over time, in conjunction with other laboratory findings and clinical assessments aids in assessing the cumulative 28-day risk of   mortality for  patients with severe sepsis or septic shock who are admitted to the intensive care unit.

The new clearance adds to the existing use of B·R·A·H·M·S PCT, cleared by the FDA in 2006, to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. Under the new clearance, PCT measurements can be obtained in emergency departments and hospital wards prior to admission to the intensive care unit. The B·R·A·H·M·S PCT test takes just 20 minutes, allowing results to be rapidly available to help determine risk of progression and mortality in septic patients and support appropriate clinical decision making. PCT levels must always be interpreted in the context of other laboratory findings and clinical assessments.

The expanded claim is a result of the multicenter Procalcitonin Monitoring Sepsis Study (MOSES), a U.S. study that investigated the relationship between the decrease in procalcitonin levels over the first four days in the hospital and outcomes in patients diagnosed with severe sepsis or septic shock. The MOSES study followed 858 adult patients, across 13 sites, who were diagnosed with severe sepsis or septic shock in an ICU or in an emergency department or medical ward prior to admission to the ICU.

The study found that patients showing a decrease in PCT less than or equal to 80 percent during the first four days following diagnosis of severe sepsis or septic shock had a two-fold increased risk of death as compared to those who experienced a decrease in PCT greater than 80 percent. The study also found that a baseline PCT measurement greater than 2.0 ng/mL is an additional mortality risk factor when evaluating PCT measurements on subsequent days.

According to MOSES lead principal investigator, Nathan I. Shapiro, M.D., MPH, attending physician at the department of emergency medicine at Beth Israel Deaconess Medical Center in Boston:

Sepsis is responsible for more than 1.6 million hospital stays with a high mortality rate. Given this reality, there is a need for additional tools to support informed decisions regarding care of patients suspected of or diagnosed with sepsis. The goal of the MOSES study was to gain a better understanding of how PCT measurement over time can provide insight into the progression of systemic bacterial infection. This can help clinicians identify patients at risk and make patient care decisions that ultimately can lead to better outcomes.

The president of Thermo Fisher’s clinical diagnostics business, Marc Tremblay, said:

Today’s announcement on the expanded FDA clearance for the B·R·A·H·M·S PCT supports the fight against sepsis-related mortality and is a testament to Thermo Fisher’s commitment in spreading awareness of sepsis with the goal of improving care. I commend Dr. Shapiro,  Dr. Philipp Schuetz, and all of the study investigators for their work on the MOSES trial, which played a vital role leading to the expanded FDA clearance for B·R·A·H·M·S PCT.