FDA Grants Market Clearance to Rapid Sepsis Test

The US Food and Drug Administration (FDA) has provided marketing clearance for a device capable of detecting specific sepsis-causing bacterial pathogens directly from a whole blood specimen in around 5 hours.

T2 Biosystems’ T2Bacteria Panel 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.

In fact, all other available FDA-approved diagnostic tests that detect bacteria in blood need a positive blood culture sample previous to the identification of bacterial species; this can delay results by up to 5 days. This delay 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%.

“The T2Bacteria Panel’s rapid results and high sensitivity make it a valuable tool for the diagnosis and management of suspected bloodstream infections,” W. Frank Peacock, MD, FACEP, FACC, professor and associate chair at Baylor College of Medicine, said in a recent statement.

The panel device was approved based on the culture-dependent tests in a pivotal trial that featured more than 1400 patients in 11 hospitals throughout the United States. 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.

The T2Bacteria pivotal trial results were nothing short of impressive, according to Minh-Hong Nguyen, MD, director of the Antimicrobial Management Program and the University of Pittsburgh Medical Center’s department of Transplant Infectious Diseases, indicating excellent performance and several 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,” Dr. Nguyen said.

As the leading cause of unplanned 30-day hospital readmissions, sepsis is a potentially lethal condition that affects over 1.5 million individuals in the United States each year, resulting in

over 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.

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 stressed.

A previous version of this article appeared on MDMagazine.com.