FDA News

T2 Biosystems seeks FDA clearance of sepsis test

Photo of John McDonough
John McDonough

T2 Biosystems submitted a 510(k) application to the FDA for its T2Bacteria Panel that will help rapidly identify pathogens associated with sepsis within hours, according to a press release. The company hopes to market the T2Bacteria Panel alongside its T2Candida Panel, a commercially available test for Candida species.

"This is a very significant milestone for the company because the addition of T2Bacteria, upon FDA clearance, may enable us to provide a comprehensive solution that enables hospitals to treat 95% of symptomatic sepsis patients with the right therapy in hours instead of days,” John McDonough, CEO of T2 Biosystems, told Infectious Disease News.

Designed to run on the FDA-cleared T2Dx Instrument, the T2Bacteria Panel would allow patients with bloodstream infections to receive targeted treatment within 8 hours of blood draw, according to the press release.

The company said the premarket submission includes data from a clinical trial that evaluated the performance of the T2Bacteria Panel compared with blood culture, as well as the performance of the panel in known bacteria-positive samples. An analysis of 1,777 clinical samples showed an average sensitivity of 95.8% and an average specificity of 98.1%.

The T2Bacteria Panel can identify six bacterial species directly from whole blood — including Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Staphylococcus aureus, according the release.

“Mortality rates for patients treated with the right therapy more quickly may be reduced, and [the T2Bacteria Panel] may enable hospitals to save tens of thousands of dollars per patient,” McDonough said. “We intend to expand our commercial focus to driving adoption of our products to the top 1,200 hospitals in the United States, with the goal of expanding testing of symptomatic patients." – by Savannah Demko

Disclosure: McDonough is the CEO of T2 Biosystems.

Photo of John McDonough
John McDonough

T2 Biosystems submitted a 510(k) application to the FDA for its T2Bacteria Panel that will help rapidly identify pathogens associated with sepsis within hours, according to a press release. The company hopes to market the T2Bacteria Panel alongside its T2Candida Panel, a commercially available test for Candida species.

"This is a very significant milestone for the company because the addition of T2Bacteria, upon FDA clearance, may enable us to provide a comprehensive solution that enables hospitals to treat 95% of symptomatic sepsis patients with the right therapy in hours instead of days,” John McDonough, CEO of T2 Biosystems, told Infectious Disease News.

Designed to run on the FDA-cleared T2Dx Instrument, the T2Bacteria Panel would allow patients with bloodstream infections to receive targeted treatment within 8 hours of blood draw, according to the press release.

The company said the premarket submission includes data from a clinical trial that evaluated the performance of the T2Bacteria Panel compared with blood culture, as well as the performance of the panel in known bacteria-positive samples. An analysis of 1,777 clinical samples showed an average sensitivity of 95.8% and an average specificity of 98.1%.

The T2Bacteria Panel can identify six bacterial species directly from whole blood — including Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Staphylococcus aureus, according the release.

“Mortality rates for patients treated with the right therapy more quickly may be reduced, and [the T2Bacteria Panel] may enable hospitals to save tens of thousands of dollars per patient,” McDonough said. “We intend to expand our commercial focus to driving adoption of our products to the top 1,200 hospitals in the United States, with the goal of expanding testing of symptomatic patients." – by Savannah Demko

Disclosure: McDonough is the CEO of T2 Biosystems.