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Rapid group A strep test clears FDA

from Medscape

The U.S. Food and Drug Administration has approved marketing clearance for the Alere i Strep A test, the first molecular test that detects group A streptococcus bacteria in throat swab specimens in eight minutes or less, the company said. "The speed and accuracy of the Alere i Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency," Avi Pelossof, Alere's global president of infectious disease, said in a news release. more


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