Rapid Sepsis Test Gets FDA Market Clearance

The US Food and Drug Administration (FDA) has approved the marketing for a device that can provide detection of specific sepsis-causing bacterial pathogens directly from a whole blood specimen in about 5 hours.

The T2Bacteria Panel, from T2 Biosystems, has been approved for the direct detection of bacterial species in the whole blood specimens of patients with possible bloodstream infections. Its processing speed significantly improves on the market’s previous standard of 3-day blood culture tests.

The panel device was approved based on the culture-dependent tests in a pivotal trial that featured more than 1400 patients in 11 US hospitals. Its tenfold improvement in time was compounded by results which showed it achieved an overall mean sensitivity of 90% and specificity of 98%, while also demonstrating no interference from the presence of bloodstream-based antibiotics.

Minh-Hong Nguyen, MD, director of the Antimicrobial Management Program and the University of Pittsburgh Medical Center’s department of Transplant Infectious Diseases, called the T2Bacteria pivotal trial results impressive, with “excellent performance and advantages over blood culture.”

“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,” Nguyen said.

Sepsis, a potentially lethal condition that affects 1.6 million U.S. patients each year, results more than 250,000 deaths (or almost 50% of all deaths) of US hospitalized patients. Studies have shown that the mortality rate for bloodstream infections can be reduced significantly with appropriate targeted therapy within 12 hours.

The panel enters a market of FDA-cleared diagnostic tests that require a positive blood culture sample prior to receive specific identification of bacterial species. The process commonly delays results 1-5 days, which can place patients at risk of sepsis in a compromising position: researchers estimate every hour of increased speed to targeted therapy decreases patient mortality by nearly 8%.

T2Bacteria Panel’s market clearance marks a significant milestone for T2 Biosystems, John McDonough, president and chief executive officer, said in a statement. It may mean even more for the millions of patients at risk of bloodstream-borne sepsis.

“This breakthrough technology provides potentially life-saving answers for patients and economic savings to hospitals that bear the enormous burden of sepsis-related care and mortality,” McDonough said.