Alere i RSV test receives FDA CLIA waiver for detection of RSV infection in children, adults

First molecular test to detect RSV infection in 13 minutes or less now widely available in a broad range of healthcare settings

Alere Inc., a global leader in rapid diagnostics, today announced that its Alere™ i RSV test has been granted CLIA (Clinical Laboratory Improvement Amendments) waiver by the U.S. Food and Drug Administration (FDA) for the detection of RSV (respiratory syncytial virus) infection in children and adults. The Alere i RSV test, which was cleared for marketing by the FDA in August 2016, is the first molecular test that can be used at the point-of-care to detect RSV in 13 minutes or less.

With CLIA waiver, the Alere i RSV test will be available in physician offices, hospital emergency rooms and walk-in clinics throughout the United States.

“Our innovative Alere i platform now offers the key trio of respiratory assays for rapid molecular detection of RSV, Influenza A & B and Strep A in a broad range of healthcare settings,” said Avi Pelossof, Alere Global President of Infectious Disease. “Healthcare providers can now deploy the power of rapid molecular testing to quickly and accurately differentiate these potentially serious infections and link patients to the appropriate treatment.”

In acute care settings, every minute counts when assessing symptomatic patients. Arming healthcare personnel with a simple-to-use, point-of-care RSV test that offers speed and molecular accuracy facilitates early and appropriate supportive care, the avoidance of unnecessary antibiotic treatment, and the rapid initiation of infection control measures to help control the spread of RSV, a highly contagious and potentially life-threatening infection.

“As of February 28, 2017, we have installed approximately 7,500 Alere i instruments across the globe. Achieving a third CLIA-waived assay on the platform demonstrates our ability to successfully bring transformational new technology to market and we look forward to further expanding the assay content and disease states of the Alere i platform,” said Pelossof.


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