Thermo Fisher Scientific Announces Expanded FDA Clearance for its B·R·A·H·M·S PCT Sepsis Biomarker

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

Tuesday, March 1, 2016 9:29 am EST

Dateline:

WALTHAM, Mass.

WALTHAM, Mass.--(BUSINESS WIRE)--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 infection1. 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.2

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 ICU2.

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 percent2. 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 days2.

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.”

About Sepsis

Sepsis is a common and frequently fatal medical condition that is the result of the body’s inflammatory response to an infection. It is the sixth most common principal diagnosis, accounting for more than 1.6 million hospital stays annually in the U.S. It is the most costly inpatient diagnosis3, with aggregate U.S. hospital costs of $20.3 billion (USD) and rising4. Sepsis mortality rates have been reported as high as 28 to 50 percent. Early identification and appropriate intervention are crucial for improving sepsis outcomes5. However, early identification can be challenging due to the non-specific symptoms of sepsis.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and more than 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.

References:

1. Brunkhorst FM et al: Kinetics of procalcitonin in iatrogenic sepsis. Intensive Care Med 1998;24(8):888-889.

2. Moses Clinical Trial Data. On file Thermo Fisher Scientific.

3. Elixhauser A et al: Septicemia in U.S. Hospitals 2009, Statistical Brief #122. Rockville, MD: Agency for Healthcare Research and Quality; 2011.

4. Torio CM et al: National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2011, Statistical Brief #160. Rockville, MD: Agency for Healthcare Research and Quality; 2013.

5. Kumar A et al: Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 2006;34(6):1589-1596.

 

Contact:

Media Contact Information:
Racepoint Global
Lauren Ginsberg, 617-624-3254
lginsberg@racepointglobal.com

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