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T2 Biosystems receives US FDA clearance for sepsis diagnostic test

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.