FDA gives clearance to Alere i Influenza A and B test

June 18, 2014

Alere, Inc., provider of point-of-care rapid diagnostic and health information solutions, has received clearance from the U.S. Food and Drug Administration (FDA) for the Alere i Influenza A & B test, a molecular test to detect and differentiate influenza A and B virus in less than 15 minutes.

The clinical performance of Alere i Influenza A & B was established in a multi-center, prospective study conducted at eight U.S. trial sites during the 2012-2013 flu season, in which 585 prospective nasal swab specimens, collected from patients presenting with influenza-like symptoms, were evaluated with Alere i, and compared to viral culture. All specimens generating discrepant results between the Alere i Influenza A & B test and viral culture were tested using an FDA-cleared RT-PCR assay to confirm influenza status.

Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Unlike polymerase chain reaction (PCR) testing, Alere’s proprietary Molecular. In Minutes (MIM) isothermal nucleic acid amplification technology (iNAT) does not require lengthy and complex thermo cycling or DNA purification, and can therefore deliver PCR-caliber results more quickly and in a broad range of settings. Alere i tests for Strep A, C. difficile, respiratory syncytial virus (RSV), and chlamydia/gonorrhea are currently in development.

Alere i Influenza A & B was launched earlier this year in Europe. Clinical trials for CLIA waiver of Alere i Influenza A & B have been completed, and the company expects to submit a CLIA waiver filing to the FDA in early Q3 2014. Clinical trials for Strep A have also been completed, and the company expects to file for 510k clearance in Q3 2014. Learn more about Alere i Influenza A & B.

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