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Singulex Will Use Thermo Fisher Scientific Dx License to Develop Next-Gen Immunodiagnostics

NEW YORK (GenomeWeb) – Singulex said today that it has signed a license and supply agreement that gives it access to the Thermo Fisher Scientific BRAHMS PCT procalcitonin immunoassay.

The firm said that it plans to combine its proprietary single molecule counting technology with the Thermo Fisher procalcitonin assay to develop a sepsis and systemic inflammatory response syndrome (SIRS) rule-out and rule-in test on its Sgx Clarity next generation immunodiagnostics platform.  

Further terms of the agreement were not disclosed.

Thermo Scientific's BRAHMS PCT assay is used in Europe to diagnose systemic bacterial infection and sepsis, and in the US to aid in assessing the risk of critically ill patients for progression to severe sepsis and septic shock, and to assess the risk of mortality in patients diagnosed with sepsis.

This summer, the FDA granted 510(k) clearance for extended use of the BRAHMS PCT sepsis test. It can now be used before a patient is admitted to the intensive care unit, whereas it previously was cleared for use with critically ill patients already in the ICU.

Thermo has licensed the test non-exclusively to both Roche and BioMérieux, who have received FDA clearance to run the test on their instruments in the US.

"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," Singulex President and CEO Guido Baechler said in a statement. "The combination of SMC-powered utility designed in the Sgx Clarity System with the proven Thermo Fisher Scientific BRAHMS PCT know-how and biomaterials will be a major advancement for the medical community."

In August, Singulex said that it had been granted ISO 13485:2012 certification by certifying body NSAI that allows it to prepare to begin marketing the Sgx Clarity system, which is undergoing market evaluation in Europe. The company said it expects to receive CE marking for the system by the end of the first quarter of 2017. Singulex plans to submit the Sgx Clarity System to the US Food and Drug Administration early next year.