FDA Clearance for Alere™ i Influenza A and B Test
Alere Inc. has received FDA clearance for the Alere™ i Influenza A & B test, the first and only 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. 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 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.
For more information on Alere i Influenza A & B, go to www.alere-i.com/us.
Tags: Clostridium difficile, Influenza, Neisseria, Respiratory Syncytial Virus, Chlamydia trachomatis
Date Published: June 17, 2014
Source article link: Alere, Inc » company contact details
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