FDA Clears Alere i RSV MDx
News Aug 22, 2016
Alere Inc. has announced that its Alere™ i RSV test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the detection of RSV infection in children and adults. Following Alere™ i Influenza A & B and Alere™ i Strep A, Alere i RSV is the latest testing application on the Alere i platform and is the first molecular test that can be used at the point-of-care to detect RSV in 13 minutes or less.
Alere will shortly submit an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere i RSV test. Alere i testing applications have previously been CLIA - waived for Influenza A & B and Strep A.
“Our innovative Alere i platform now allows for the rapid molecular detection of RSV, Influenza A & B and Strep A,” said Avi Pelossof, Alere Global President of Infectious Disease. “The availability of clinically meaningful results in an actionable timeframe empowers clinicians to deliver prompt and appropriate patient care. We are excited to continue our ground-breaking innovation on this platform with multiple new analytes progressing well through product development.”
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 this highly contagious and potentially life-threatening infection.