Thermo Fisher Scientific Trial Design Helps Accelerate FDA Clearance Process for B·R·A·H·M·S PCT License Partners

Innovative banked specimen trial design aids in streamlining regulatory review for two license partners, achieving clearance in 90 days.

Thursday, July 7, 2016 8:00 am EDT

Dateline:

WALTHAM, Mass.
"Thermo Fisher Scientific is committed to aiding in the fight against sepsis. This innovative approach to accelerating and expanding PCT market availability is just one more example of this commitment"

WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific, Inc., the world leader in serving science, today announced it pioneered an innovative trial design that helped its license partners, Roche Diagnostics USA and bioMérieux, achieve FDA clearance in just 90 days for the Roche ELECSYS B·R·A·H·M·S PCT and bioMérieux VIDAS B·R·A·H·M·S PCT assays. Together with the Thermo Scientific B·R·A·H·M·S PCT sensitive KRYPTOR, these are the only procalcitonin (PCT) assays cleared for clinical use in the U.S. PCT is a sensitive and specific biomarker of the inflammatory response to bacterial infection associated with sepsis.1

The novel trial design leveraged banked specimens from Thermo Fisher Scientific’s U.S. multicenter Procalcitonin MOnitoring SEpsis Study (MOSES). Using the same patient samples from the MOSES study enabled a “universal analysis” approach to demonstrate substantial equivalence of the partners’ assays to Thermo Fisher’s previously cleared B·R·A·H·M·S PCT sensitive KRYPTOR. This enabled Roche and bioMérieux to file for clearance without the significant time and expense required to conduct their own clinical trials.

All assays produced under the B·R·A·H·M·S PCT brand utilize the same standardized reference, ensuring high concordance at clinically relevant cutoffs, regardless of platform. The clinical value of B·R·A·H·M·S PCT has been demonstrated through seven years of use in the U.S. and 20+ years of use outside the U.S., supported by an evidence base of more than 3,500 published studies.

“Thermo Fisher Scientific is committed to aiding in the fight against sepsis. This innovative approach to accelerating and expanding PCT market availability is just one more example of this commitment,” said Marc R. Tremblay, President, Clinical Diagnostics Division at Thermo Fisher Scientific. “We congratulate Roche Diagnostics USA and bioMérieux, and we look forward to working with our other license partners to further expand clinicians’ access to this valuable tool for septic patient management.”

About the MOSES Study
The 2015 Procalcitonin MOnitoring SEpsis Study (MOSES) was conducted to validate the use of B·R·A·H·M·S PCT (procalcitonin) in assessing the all-cause mortality risk of patients with sepsis. The study included 858 adult patients with sepsis recruited across 13 investigational sites in the U.S. The study found that the change in PCT over time aids in assessing cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock. The study also found a 2-fold risk of death for individuals with a decrease in PCT less than or equal to 80% compared with those with a PCT decrease of more than 80% during the first four days following ICU admission. In addition, a baseline PCT measurement greater than 2.0 ng/mL is an additional factor to consider when evaluating PCT measurements on subsequent days. Based on the findings of the MOSES study, the FDA expanded B·R·A·H·M·S PCT sensitive KRYPTOR clearance to include its use in mortality risk assessment over time, aiding in septic patient management.

About Sepsis
Sepsis is a systemic inflammatory response to infection with some degree of organ dysfunction that can progress to organ failure and death.2 Each year, more than 266,000 deaths in the U.S. are attributed to sepsis (2009).3 It is the sixth most common principal diagnosis in the U.S., accounting for more than 1.6 million hospital stays.3 It is the most costly inpatient diagnosis, with aggregate annual hospital costs totaling $20.3 billion (2011).4 Early identification and intervention are crucial to improving sepsis outcomes,1 making rapid, more reliable detection a national, if not global, imperative.

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 visitwww.thermofisher.com.

1. 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.
2. Vincent JL et al: Sepsis definitions: time for change. Lancet 2013;381:774-775.
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.

Contact:

Media Contact
Racepoint Global
Sally Bain, 617-624-3223
M: 617-834-6026
sbain@racepointglobal.com

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