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T2 Biosystems Inc., a Lexington, Mass.-based developer of diagnostics for rapid identification of dangerous pathogens, has reached a key regulatory milestone that could alter its near-term future, according to one analyst.
Ben Haynor, an analyst at Alliance Global Partners, said the Food and Drug Administration’s clearance of the company’s T2Biothreat panel, which detects six pathogens — the organisms that cause anthrax, tularemia, glanders, melioidosis, plague and typhus — within four hours, is a potential game changer for…