Thermo Fisher Scientific Announces Sixth Licensing Agreement for B·R·A·H·M·S PCT

Siemens Healthineers Recent FDA Clearance of the Atellica IM B·R·A·H·M·S PCT Assay Extends Access of Procalcitonin to More U.S. Laboratories

WALTHAM, Mass., Oct. 2, 2018 –Thermo Fisher Scientific Inc., today announced the sixth licensing agreement for its B·R·A·H·M·S PCT (procalcitonin) biomarker that provides information on the presence and severity of bacterial infections. B·R·A·H·M·S PCT aids physicians in emergency departments (ED), intensive care units (ICU) and other hospital specialties in deciding whether to initiate antibiotic therapy in patients with suspected or confirmed lower respiratory tract infections (LRTI) and when to safely discontinue antibiotics in patients with LRTI and sepsis. Siemens Healthineers joins a leading group of healthcare technology partners that includes Abbott, bioMérieux, DiaSorin, Fujirebio and Roche, all of whom are dedicated to continued innovation to aid in early sepsis detection and reducing inappropriate antibiotic use in hospital patients.

Siemens Healthineers Atellica IM B·R·A·H·M·S PCT assay received FDA clearance on July 16, 2018. In clinical studies, B·R·A·H·M·S PCT has been shown to reduce the antibiotic prescription rate and duration in patients with LRTIs such as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Evaluating the decline in B·R·A·H·M·S PCT levels over time aids clinicians in determining whether to discontinue antibiotic therapy for patients with LRTI or sepsis. The Atellica IM B·R·A·H·M·S PCT assay can also aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis, assessing the risk of critically ill patients who progress from severe sepsis to septic shock, and help determine the 28-day all-cause mortality risk in sepsis patients.

The value provided by the B·R·A·H·M·S PCT biomarker is underscored by the FDA's recent clearance of extended claims. In 2016, the biomarker was cleared to use in assessing the risk of critically ill patients who were diagnosed with severe sepsis or septic shock and to help determine the 28-day all-cause mortality risk in sepsis patients. This clearance served to expand use of the biomarker outside of ICU into the ED and General Ward for sepsis and all risk mortality. In 2017, the biomarker was cleared to assist in decision making on antibiotic therapy for patients with suspected or confirmed LRTI in an inpatient setting or an emergency department and to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

"The Siemens Healthineers Atellica IM B·R·A·H·M·S PCT assay is another example of our commitment to precision medicine and to delivering a comprehensive assay menu for the Atellica Solution," said Andy Olen, senior vice president, Laboratory Diagnostics, North America, Siemens Healthineers. "The Atellica IM B·R·A·H·M·S PCT assay is a good tool as an aid in sepsis assessment, assigning mortality risk, and antibiotic therapy decision making in the ED and ICU. Early diagnosis and treatment of sepsis is associated with better patient outcomes."

"With more than 5,000 customers in 130 countries it is clear that expanding availability of the PCT biomarker benefits patients and communities," said Patrick Durbin, senior vice president and president of specialty diagnostics for Thermo Fisher Scientific. "B∙R∙A∙H∙M∙S PCT offers consistent results across all platforms and helps health care practitioners make safe clinical decisions as they determine whether to initiate, and when to stop, antibiotic therapy in certain patients."

About B·R·A·H·M·S PCT (Procalcitonin)

B·R·A·H·M·S PCT is the first and leading procalcitonin (PCT) assay cleared for clinical use in the U.S. In use in many European countries since 1996, the value of B·R·A·H·M·S PCT in supporting care of critically ill and septic patients has been reinforced through more than 4000 publications in the U.S. and in Europe. PCT is included in antibiotic stewardship guidelines issued by IDSA (Infectious Disease Society of America) and the Surviving Sepsis Campaign.1,2

Availability of this product in each country depends on local regulatory marketing authorization status. For more information, please see the following site: About Sepsis.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 employees globally. 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, deliver medicines to market 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 services. For more information, please visit www.thermofisher.com.

1 Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2016.

2 Barlam T, et al., Guideline for Implementing an Antibiotic Stewardship Program, Infectious Diseases Society of America, CID 2016:62.

 

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