A novel trial design shares patient samples and takes a "universal analysis" approach to accelerate sepsis assays to FDA clearance.
Two sepsis assays recently attained FDA clearance in 90 days, a feat made possible by a partnership and innovative trial design.
Earlier this month, Thermo Fisher Scientific, Inc., announced that its 2016 Procalcitonin MOnitoring SEpsis Study (MOSES) trial design allowed license partners Roche Diagnostics USA and bioMérieux to gain quick regulatory clearance. Both the Roche Elecsys BRAHMS PCT assay and the bioMérieux VIDAS BRAHMS PCT assay are now cleared to help assess risk and manage sepsis patients after diagnosis. Roche Diagnostics USA ...