FDA Waiver Of Alere Inc.'s Flu Test Poses Threat to Cepheid

Lost in the slew of news from health care companies last week was an approval announced by Alere that could have practical significance for all of us regarding one of its biggest-selling tests for influenza.

The U.S. Food and Drug Administration deemed the Waltham diagnostic firm’s “i Influenza A & B” test, first approved last July, able to be offered outside of a laboratory. That means the test for influenza, previously offered primarily at hospitals, can now be offered in doctor’s offices and even retail stores, and may eventually end up in large chain pharmacies like CVS or Walgreens.

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