Alere Inc. announced that it has received clearance from the FDA for a rapid molecular test that can detect and differentiate influenza A and influenza B viruses within 15 minutes.
According to the company, the influenza A and B molecular test (Alere i) uses isothermal nucleic acid amplification technology, which does not require thermal cycling or DNA purification like polymerase chain reaction (PCR) assays, allowing for faster results.
The clinical performance of the Alere influenza test was established in a multicenter, prospective study conducted in the United States during the 2012-2013 influenza season. In the study, 585 nasal swab specimens collected from patients presenting with influenza-like illness were evaluated using the Alere test. Results were then compared to viral culture, and discrepant samples were resolved using an FDA-approved PCR assay.
“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, global president of infectious disease at Alere, said in a press release.
In January, the Alere test was launched in Europe. Clinical trials for a Clinical Laboratory Improvement Amendments (CLIA) waiver have been completed, and the company plans to submit a CLIA waiver filing to the FDA later in the year.