Alere Inc., a global provider of point-of-care rapid diagnostic and health information solutions, recently announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Alere™ i Influenza A & B test, the first molecular test to detect and differentiate influenza A and B virus in less than 15 minutes.
“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,” said Avi Pelossof, Alere Global President of Infectious Disease.
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.
Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform. 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.
Alere is headquartered in Waltham, Massachusetts. Alere Inc. The company recently announced that it had elected not to proceed with plans to pursue an initial public offering in the United Kingdom of the ordinary shares of BBI Diagnostics Group plc, or BBI Diagnostics.
Source: Alere Inc., adapted.