Thursday, January 8, 2015

Alere Receives FDA CLIA Waiver for Alere™ i 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.

"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.

About the Alere i Influenza A & B test

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 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.

The clinical performance of Alere i Influenza A & B was established in a multi-center study conducted in the U.S., in which 630 nasal swab specimens, were evaluated with Alere i, and compared to an FDA cleared Real-Time PCR (RT-PCR) assay.

Additional tests on the Alere i platform are currently in development. Alere recently filed a 510k application for Strep A, and the company is planning to initiate clinical trials for a respiratory syncytial virus (RSV) test during the current respiratory season.

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