FDA Clears 15-Minute Influenza Test

The Food and Drug Administration has cleared the Alere i Influenza A & B Test, the only test that can detect and differentiate flu A and B virus in under 15 minutes.

Unlike traditional flu tests, which involve polymerase chain reaction testing, the new isothermal nucleic acid amplification technology doesn't require thermo cycling or DNA purification, allowing quicker delivery of results.

"By providing the speed of a rapid test with molecular technology, Alere i delivers clinically meaningful and actionable results to clinicians — enabling them to treat patients more quickly and appropriately," Avi Pelossof, Alere global president of infectious disease, said in a news release.

Alere is also developing Alere i tests for strep A, C. difficile, respiratory syncytial virus and Chlamydia/gonorrhea.

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