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Device Company, Medical Center Partner on Blood Infections Trial

Pseudomonas aeruginosa

Pseudomonas aeruginosa colony (Harvard Medical School, NIH)

9 June 2023. A developer of detection systems for infections and university medical center plan a clinical trial to evaluate a sepsis device for helping patients with blood stream infections. T2 Biosystems Inc. in Lexington, Mass. is collaborating with Vanderbilt University Medical Center in Nashville, Tennessee to assess the T2Bacteria Panel, a device for quickly detecting sepsis infections in hospitalized patients.

The T2Bacteria Panel uses the T2 Biosystems process called T2MR that adapts magnetic resonance in a miniaturized form to measure behavior of water molecules in the presence of a magnetic field. T2MR, says the company, can be used to directly detect pathogens in several types of fluids: whole blood, serum, plasma, urine, saliva, and sputum. And according to T2 Bio, samples do not need pre-extraction or purification, which reduces the time needed for analysis. In addition, says the company, T2MR works with target molecules in low concentrations, increasing the true-positive sensitivity of its readings. T2 Biosystems was formed in 2006 to commercialize the technology, based on research at MIT and Harvard Medical School.

Majority of blood stream infections

The T2Bacteria Panel is one of the company’s lead products, designed to test blood samples for sepsis, a dangerous infection that becomes life-threatening. The company says the device assesses whole blood for five bacteria — E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, and E. coli — returning results in three to five hours. T2 Bio cites data showing these bacteria account for a majority of blood stream infections, particularly in health care settings, and are becoming more difficult to treat, making early detection and treatment vital for hospitalized patients. The company says the T2Bacteria Panel is cleared by the Food and Drug Administration for sepsis detection in the U.S. and received a CE mark, authorizing its use in Europe.

T2 Bio is collaborating with Vanderbilt University Medical Center on a prospective clinical trial to evaluate the T2Bacteria Panel as a tool for improving the hospital’s use of antibiotics in treating patients with blood stream infections. The trial is part of Vanderbilt’s Center for Learning Healthcare, a program started earlier this year to generate evidence for improving the quality, safety, and value of its health care services. The Center for Learning Healthcare also supports comparative effectiveness research and pragmatic clinical trials, studies that assess treatments in real-world settings.

“The Vanderbilt Learning Healthcare system platform,” says John Sperzel, chairman and CEO of T2 Biosystems in a company statement released through Globe Newswire, “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.”

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