T2 Biosystems Inc. received market clearance from the U.S. Food and Drug Administration for its T2Bacteria Panel which directly detects bacterial species in patients with suspected bloodstream infections.
The Lexington, Mass.-based diagnostic products maker said its test provides detection of specific sepsis-causing bacterial pathogens directly from a whole blood specimen in about 5 hours, faster than other FDA-cleared diagnostic tests.
The company said bacterial and fungal bloodstream infections are a leading cause of sepsis, a life-threatening illness that affects 1.6 million U.S. patients each year, resulting in over 250,000 deaths, or about 50% of all deaths of U.S. hospitalized patients.
