FDA clears T2Bacteria Panel for sepsis diagnosis
T2 Biosystems announced today that it has received market clearance from the FDA for its T2Bacteria Panel, which the company said can identify pathogens associated with sepsis within hours.
“T2Bacteria is the first and only diagnostic that can identify specific sepsis-causing bacteria directly from a whole-blood specimen in approximately 5 hours without the need to wait for the results of a blood culture,” John McDonough, CEO of T2 Biosystems, said during a teleconference. “This represents a major breakthrough in the field of diagnostics, and more specifically, in the management of patients at risk for sepsis, which continues to be one of the most costly issues both in terms of mortality rate and actual dollars spent in the health care system.”
The new assay runs on the FDA-cleared T2Dx Instrument, which can also be used to test and monitor Candida auris infections with the T2Candida Panel (T2 Biosystems). The efficacy of the T2Bacteria Panel was assessed during a clinical trial involving more than 1,400 patients with suspected bloodstream infections at 11 hospitals in the United States. Data presented by Minh-Hong Nguyen, MD, director of the Antimicrobial Management Program and Transplant Infectious Diseases at the University of Pittsburgh, at the European Congress of Clinical Microbiology and Infectious Diseases, showed the T2 Bacteria Panel accurately detected sepsis-causing pathogens, including Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Staphylococcus aureus, with an average sensitivity of 90% and specificity of 98%. Results were obtained more than 2.5 days faster than with traditional blood culture-dependent tests.
“The results from the T2Bacteria pivotal clinical trial were impressive, demonstrating excellent performance and advantages over blood culture,” Nguyen said in a press release. “T2Bacteria’s detection of bloodstream infections and fast species identification at high sensitivity will expedite life-saving interventions such as the targeting of therapy within hours of blood draw.”
McDonough said additional data on the T2Bacteria Panel will be presented at several upcoming scientific conferences, including ASM Microbe.
Nguyen MH, et al. Abstract O1092. Presented at: European Congress of Clinical Microbiology and Infectious Diseases; April 21-24, 2018; Madrid.
Disclosures: McDonough is CEO of T2 Biosystems. Infectious Disease News was unable to confirm Nguyen’s relevant financial disclosures at the time of publication.