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.
The Scripps Research Institute has disclosed Ras-related protein Rab-27A/synaptotagmin-like protein 1 (SYTL1; JFC1) interaction inhibitors reported to be useful for the treatment of endotoxemia, sepsis, systemic inflammatory response syndrome and cryopyrin-associated periodic syndromes (CAPS).
Enlivex Therapeutics Ltd. extolled the top-line “positive indication of effect and safety” from the phase II study of Allocetra in treating sepsis and sepsis shock, but the market took another view of the clinical trial. In an analysis of eligible adult patients from the cell therapy’s multicenter, randomized, placebo-controlled, dose-finding study of 120 enrolled patients, the company also reported low mortality rates.
Bone morphogenetic protein 9 (BMP-9), also known as growth/differentiation factor 2, is a member of the transforming growth factor-β family of cytokines, which exerts its biological effects through binding to a complex formed by ALK1 and BMPR2.
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is awarding Syntiron US$1.7 million to develop a maternal vaccine that targets Escherichia coli and Klebsiella pneumoniae, two bacterial species that cause a large portion of neonatal sepsis infections.
Asep Medical Holdings Inc. is expanding operations into China with a joint venture (JV) with Chinese medical diagnostics firm Sansure Biotech Inc., ramping up the race to commercialize sepsis diagnostics in Asia.
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.
Asep Medical Holdings Inc. is expanding operations into China with a joint venture (JV) with Chinese medical diagnostics firm Sansure Biotech Inc., ramping up the race to commercialize sepsis diagnostics in Asia.
The time to diagnosis of sepsis infection to a patient in the hospital can be critical, with underdiagnosis resulting in rapid deterioration, risk of organ damage and need for readmission, and overdiagnosis leading to the avoidable and sometimes serious health consequences of overtreating patients with broad-spectrum antibiotics.
Day Zero Diagnostics Inc. and Oxford Nanopore Technologies plc (ONT) joined forces to battle the leading cause of death in hospitals — sepsis. Combining Day Zero’s whole genome sequencing technology for pathogen identification and antimicrobial susceptibility analysis with Oxford’s nanopore-based molecular sensing technology, the companies aim to develop a diagnostic system that provides potentially life-saving identification and guidance on antimicrobial selection in mere hours.