T2Biosystems Announces FDA Approval For Sepsis Test: 'This Is A Game-Changer'

T2 Biosystems Inc TTOO announced Tuesday that it received FDA approval for a blood test to detect sepsis; the stock is down more than 11 percent in morning trading. 

What Happened

T2 Biosystems announced the FDA's market clearance for its T2Bacteria Panel. The panel is meant to directly detect bacterial species in human whole blood specimens from patients with suspected bloodstream infections.

Why It's Important

The panel sensitively detects sepsis-causing bacterial pathogens directly from a whole blood specimen in about five hours, about 2 1/2 days faster than blood culture-dependent tests.

"This is an important breakthrough, as bacterial infections are a major cause of poor patient outcomes and high hospital costs. This is a game-changer," Frank Peacock, a professor and associate chair at the Baylor College of Medicine, said in a statement. 

The FDA-cleared T2Bacteria Panel identifies five of the most common and deadly sepsis-causing species of bacteria: enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa  and Staphylococcus aureus, the company said in the release.

Bacterial and fungal bloodstream infections are a leading cause of sepsis, a life-threatening illness affecting 1.6 million U.S. patients per year, resulting in over 250,000 deaths — or about 50 percent of all deaths of U.S. hospitalized U.S. patients.

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Photo courtesy of T2 Biosystems.