Alere Announces FDA CLIA Waiver for Alere Influenza A&B Test

Alere Inc.

, a global leader in rapid diagnostic tests, today announced that the U.S. Food and Drug Administration (FDA) has granted CLIA waiver for the Alere™ i Influenza A & B test, the only molecular test to detect and differentiate influenza A and B virus in under 15 minutes. Alere i Influenza A & B is the first-ever molecular test to receive a CLIA (Clinical Laboratory Improvement Amendments) waiver, which allows for broad use by healthcare providers, ranging from hospitals and physician offices to clinics and other healthcare settings. First-ever CLIA-waived molecular flu test delivers lab-accurate results at the point of care in less than 15 minutes "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 Disease 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." The Alere i test was cleared for marketing by the 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 CLIA waiver, the test will be available in a significantly broader range of healthcare settings.