T2 Biosystems has announced a collaboration with US-based Vanderbilt University Medical Center’s (VUMC) Learning Healthcare System Platform to assess the T2BacteriaPanel for clinical applications.
As part of the collaboration, VUMC will be responsible for implementing and assessing the T2BacteriaPanel in a clinical setting.
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It will carry out a prospective trial to evaluate the direct-from-blood test to enhance antibiotic usage and clinical interventions for bloodstream infection patients.
Approved by the US Food and Drug Administration (FDA), the diagnostic test can identify sepsis-causing bacterial pathogens directly from whole blood within three to five hours.
Designed to run on the fully automated T2Dx Instrument, the test simultaneously identifies five bacteria species: P. aeruginosa, E. coli, E. faecium, S. aureus and K. pneumoniae.
The CE-marked version identifies the aforesaid pathogens and A. baumannii.
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By GlobalDataT2 Biosystems chairman and CEO John Sperzel said: “Vanderbilt University Medical Center is one of the leading healthcare institutions in the country and we are excited to partner with them to bring our life-saving sepsis pathogen detection products to their patients and providers.
“The Vanderbilt Learning Healthcare System Platform provides a unique opportunity to show the benefit of rapid, culture-independent diagnostics and further demonstrate the value of the T2Bacteria Panel in rapidly identifying causative bacterial pathogens in septic patients.”
Last month, the company submitted a 510(k) premarket notification with the US FDA for its T2Biothreat Panel.
