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Alere Gets FDA Clearance for Molecular Flu A/B Test

NEW YORK (GenomeWeb) — Alere said today that it has received US Food and Drug Administration Clearance for the Alere i Influenza A&B test.

According to Alere, the new assay is the only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. The test uses Alere's proprietary "Molecular. In Minutes" (MIM) isothermal nucleic acid amplification technology, which unlike PCR does not require thermal cycling or DNA purification, thus reducing time to result.

Alere established the assay's clinical performance in a multi-center, prospective study conducted on 585 nasal swab specimens collected at eight US trial sites during the 2012-2013 flu season.

Alere, based in Waltham, Mass., launched the i Influenza A&B test earlier this year in Europe. The company has also completed clinical trials for CLIA waiver of the test, and expects to submit a CLIA waiver filing to the FDA in the third quarter.