Influenza Detection Test Receives FDA CLIA Waiver

The Alere i influenza A and B test developed and marketed by Alere Inc. has been granted a Clinical Laboratory Improvement Amendments (CLIA) waiver by the U.S. Food and Drug Administration (FDA). Alere i is the only molecular test to detect and differentiate influenza A and B virus in under 15 minutes. It was cleared for marketing by FDA in June 2014 and was made available in September for health facilities and laboratories licensed to conduct tests of moderate complexity under the CLIA program. With the CLIA waiver, the test will be available in a significantly broader range of healthcare settings, including hospitals, physician offices and clinics. “This milestone greatly expands the availability of molecular testing to a wide range of healthcare settings during this influenza season,” said Avi Pelossof, global president of infectious diseases at Alere. “By making lab-accurate, actionable results available at the point of care, Alere i empowers healthcare providers to quickly identify and treat people with influenza — improving patients’ clinical outcomes, protecting their communities and reducing healthcare costs.”