Next Generation Immunodiagnostics for Sepsis Diagnostics

New agreement provides Singulex access to Thermo Scientific BRAHMS PCT (Procalcitonin), a biomarker used to diagnose sepsis. Sepsis and systemic inflammatory response syndrome (SIRS) are potentially life-threatening complications of infection which can bring significant health and economic cost if not identified and treated early.

Singulex is utilizing their proprietary Single Molecule Counting technology to develop a sepsis and SIRS rule-out and rule-in test using the Procalcitonin biomarker for the Sgx Clarity system. The Sgx Clarity System, currently in development and not yet approved for sale, is a fully automated, Next Generation Immunodiagnostics platform designed to bring the benefits of Singulex’s SMC™ technology to hospital and reference labs worldwide.

“The agreement with Thermo Fisher marks an important milestone in the diagnosis and treatment of sepsis and SIRS, a significant global health concern,” said Guido Baechler, president and chief executive officer, Singulex. “It is also another validation of the power of Singulex’s Next Generation Immunodiagnostics platform powered by SMC. Building on our proven success in cardiac troponin diagnostic analysis, our plan is to develop and commercialize sepsis and SIRS rule-out and rule-in tests for use on our Sgx Clarity System. The combination of SMC-powered utility designed in the Sgx Clarity System with the proven Thermo Scientific BRAHMS PCT know-how and biomaterials will be a major advancement for the medical community.”

SMC is proven to be more than a hundred times more sensitive than currently available assay technology. This unprecedented sensitivity is designed to bring greater utility to identify sepsis and SIRS and potentially enable earlier disease detection. Earlier and more confident detection and diagnosis benefits both patient outcomes and helps reduce healthcare cost. According to the U.S. Agency for Healthcare Research and Quality, sepsis is considered the most expensive condition treated in the United States, costing more than $23 billion USD in 2013, and rising¹.

Thermo Fisher Scientific is a recognized leader in serving science and developing biomarkers which guide the diagnosis and management of disease. Their BRAHMS PCT biomarker is a breakthrough in the field of sepsis diagnosis. Application of SMC technology with the BRAHMS PCT biomarker will allow the identification of Procalcitonin at levels previously unachievable.

The unprecedented sensitivity and utility of Singulex’s SMC technology is designed to aid physicians with earlier and more confident identification of this potentially life-threatening condition. By identifying biomarker levels with greater sensitivity than currently available tests, physicians may detect disease earlier, a critical step for patients particularly those in emergency rooms, intensive care or neonatal intensive care units.

¹ National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2013, Celeste M. Torio, Ph.D., M.P.H., and Brian J. Moore, Ph.D. May 2016