T2 Biosystems announces results from T2Bacteria Panel trial publsihed
T2 Biosystems announced that results from a pivotal trial were published online in the Annals of Internal Medicine journal. The study demonstrated evidence for the first direct-from-blood, non-culture test cleared by the FDA for the diagnosis of bloodstream infections by multiple bacteria. Blood cultures took between 32 and 111 hours to identify pathogens whereas the T2Bacteria Panel took 3.6 to 7.7 hours to do so. In 78% of probable or possible bloodstream infections, or BSIs, subjects had blood culture-negative/T2Bacteria positive results despite treatment with active antibiotics. A total of 24 hours after blood draw, 20% of patients with blood culture-positive/T2bacteria-positive results were still not receiving effective therapy. The T2Bacteria Panel had a 99.7% negative predictive value and an overall sensitivity of 89.7% per subject and per assay. The T2Bacteria Panel had overall specificity of 89.5% per subject and 97.8% per assay.