A rapid diagnostic test from Ocean Dx SAS delivered gold standard performance in a clinical evaluation that points to a potential shift in how sepsis is identified and treated. The assay, which detects more than 1,000 bacterial species directly from whole blood, returned 100% sensitivity and 100% specificity compared with reference blood cultures, with results reported in five hours. Further, the test tripled the number of infections identified.
Just a few weeks later than expected, Inflammatix Inc. secured U.S. FDA clearance of the Triverity test system for use in emergency triage of patients with suspected acute infection or sepsis. The molecular blood test is the first to identify bacterial and viral infections and provide an all-cause risk evaluation of the likelihood of developing severe illness.
When every hour’s delay in treatment increases the risk of death 8%, dialing down time to diagnosis takes on acute urgency for clinicians and regulators. When the disease being treated kills 20% of the global population and 33% of hospitalized patients in the U.S., the market opportunity attracts investors. And when the technology makes breakthroughs possible that cut the time to targeted treatment from days to hours or even minutes, the number of products in development explodes, as the keen competition in sepsis diagnostics covered by BioWorld in 2024 demonstrates.
Prenosis Inc. gained U.S. FDA de novo marketing authorization for an artificial intelligence-powered rapid diagnostic tool for sepsis, one of the most challenging and deadly conditions in hospitals and reported a distribution agreement with Roche Holding AG. Another pairing also made progress in developing a sepsis in vitro diagnostic this week, as Bosch Healthcare Solutions GmbH and Randox Laboratories Inc. joined forces and committed €150 million (US$159.63 million) to the effort.
Inflammatix Inc. received U.S. FDA breakthrough device designation for its Triverity acute infection and sepsis test system, which produces three readouts that could help emergency physicians quickly determine the proper course of treatment.
Inflammatix Inc. raised $102 million in series D financing to advance development and commercialization of its novel immune response diagnostics portfolio. D1 Capital Partners led the round, with additional funds provided by existing investors Northpond Ventures LLC, Khosla Ventures, Think.Health GmbH, and OSF Healthcare Ventures, among others.
