Tag Archives: T2 Biosystems

June 2021—T2 Biosystems announced that Expert Review of Medical Devices published meta-analysis findings confirming that using the company’s magnetic resonance (T2MR) technology for identification of bloodstream infections provides faster time to detection, faster transition to targeted microbial therapy, faster de-escalation of empirical therapy, and shorter intensive care unit and hospital stay, and with comparable mortality rate versus the current blood culture standard (Giannella M, et al. Online ahead of print April 16, 2021. doi:10.1080/17434440.2021.1919508). Study authors systematically searched Medline, Embase, and Cochrane Central Register of Controlled Trials for randomized trials or observational controlled studies of patients with suspected bloodstream infections receiving a diagnosis with T2MR or blood culture, ultimately including 14 studies.

December 2019—T2 Biosystems announced that its T2Resistance Panel is available as a research use only test in the United States. The panel is expected to receive the CE mark by the end of 2019.

November 2019—The Centers for Medicare and Medicaid Services granted approval for a new technology add-on payment (NTAP) to T2 Biosystems’ T2Bacteria Panel, for fiscal year 2020. The T2Bacteria Panel is the first in vitro diagnostic test to receive approval for NTAP, according to the company.

June 2019—T2 Biosystems (Lexington, Mass.) announced that a study demonstrating the advantages of its T2Bacteria Panel and how it can aid in diagnosing bloodstream infections was published in the Annals of Internal Medicine.

June 6, 2019—T2 Biosystems (Lexington, Mass.) announced that a study demonstrating the advantages of its T2Bacteria Panel and how it can aid in diagnosing blood stream infections was published in the Annals of Internal Medicine (Nguyen MH, et al. Epub ahead of print May 14, 2019). The panel identifies five ESKAPE bacteria--Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, andEscherichia coli—in three to five hours.

January 2016—T2 Biosystems presented data at the AMP annual meeting on its investigational T2Bacteria Panel. The data demonstrate the ability of T2Bacteria to provide rapid and sensitive identification of six sepsis-causing bacteria, directly from whole blood, with limits of detection as low as 1 CFU/mL.

December 2014—T2 Biosystems received FDA market authorization for its T2Candida Panel and T2Dx Instrument for the direct detection of candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing patients to, invasive fungal infections.