Seeking Alpha

Regulatory clearance for Alere flu test

  • Via its 510k process, the FDA approves Alere's (ALR +1.9%) i Influenza A&B diagnostic test, the only molecular test that can detect and differentiate the influenza A and B virus in less than 15 minutes. The product was launched in Europe earlier this year.
  • The firm has rapid molecular tests in development for Strep A, C. difficile, RSV and chlamyida/gonorrhea.
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